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Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02487966
Collaborator
Massachusetts Eye and Ear Infirmary (Other)
132
Enrollment
2
Locations
4
Arms
101.7
Duration (Months)
66
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).

Condition or Disease Intervention/Treatment Phase
  • Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©)
  • Behavioral: Mirror Therapy: active
  • Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
  • Behavioral: Mirror Therapy: Sham
 N/A

Detailed Description

Phantom limb pain (PLP) belongs to a group of neuropathic pain syndromes that is characterized by pain in the amputated limb. Rehabilitation for chronic pain involves a structured treatment plan targeting all dimensions of the pain experience, and should include a comprehensive interdisciplinary approach that allows patients to receive the most benefit according to their needs. As in other chronic pain syndromes, chronic Phantom limb pain (PLP) is often difficult to treat; showing to be resistant to classical pharmacological and surgical treatment approaches.

In this context, we hypothesize that novel treatments of PLP need to target specific neural networks associated with this maladaptive plasticity. Transcranial direct current stimulation (tDCS,Soterix ©) is a powerful and non-invasive technique of brain stimulation that is known to significantly modulate plasticity and alleviate chronic pain in various syndromes. device for this trial. This study usiGiven tDCS underlying neural mechanisms, it is critical to use a multimodal approach to treatment - using both tDCS and behavioral therapy simultaneously. In this case, an ideal therapy is mirror therapy (MT).

Recently, we showed that anodal tDCS can induce a selective short-lasting relief from PLP, and repeated applications of anodal tDCS induces long-lasting analgesic effects. These preliminary results show that tDCS may be a promising rehabilitative tool for the management of chronic PLP. This neurorehabilitation technique is commonly used in PLP, and is designed to modulate cortical mechanisms of pain by performing movements using the unaffected limb in front of a mirror. We propose to carry out a mechanistic, factorial, randomized controlled trial to evaluate a novel rehabilitation approach combining tDCS and MT in PLP patients. We aim to compare the brain changes before and after treatment in order to study the mechanisms underlying PLP.

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Mar 27, 2020
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active tDCS and Active Mirror Therapy

Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.

Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.

Behavioral: Mirror Therapy: active
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.
Experimental: Active tDCS and sham Mirror Therapy

Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.

Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.

Behavioral: Mirror Therapy: Sham
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Experimental: Sham tDCS and active Mirror Therapy

Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.

Behavioral: Mirror Therapy: active
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.

Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
Sham Comparator: Sham tDCS and sham Mirrory Therapy

Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.

Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.

Behavioral: Mirror Therapy: Sham
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.

Outcome Measures

Primary Outcome Measures

  1. Changes in the Visual Analog Scale for Phantom Limb Pain [4 weeks]

    The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

Secondary Outcome Measures

  1. Changes in the Visual Analog Scale for Stump Pain [4 weeks]

    The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

  2. Changes in the Visual Analog Scale for Phantom Limb Sensation [4 weeks]

    The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Able to provide informed consent to participate in the study.

  2. Subject is older than 18 years.

  3. Unilateral lower limb amputation.

  4. Traumatic amputation greater than 1 year ago.

  5. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week.

  6. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).

  7. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

Exclusion Criteria:

  1. Pregnancy or trying to become pregnant in the next 2 months.

  2. History of alcohol or drug abuse within the past 6 months as self-reported.

  3. Presence of the following contraindication to transcranial direct current stimulation and transcranial magnetic stimulation

  • Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel)

  • Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator)

  1. History of chronic pain previous to the amputation.

  2. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported

  3. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).

  4. Uncontrolled Epilepsy or prior seizures within the last 1 year.

  5. Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*

  6. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.

  7. History of neurosurgery, as self-reported.

  8. Mirror Therapy in the previous 3 months

Contacts and Locations

Locations

Site City State Country Postal Code
1 Spaulding Rehabilitation Network Research Institute Charlestown Massachusetts United States 02129
2 IMREA HCFMUSP - Rede Lucy Montoro São Paulo Brazil 04116-030

Sponsors and Collaborators

  • Spaulding Rehabilitation Hospital
  • Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Felipe Fregni, MD, PhD, MPH, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT02487966
Other Study ID Numbers:
  • 2015P001065
First Posted:
Jul 2, 2015
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Felipe Fregni, MD, PhD, MPH, Principal Investigator, Spaulding Rehabilitation Hospital
tDCS
Mirror Therapy
Phantom Limb Pain
Traumatic amputation
Additional relevant MeSH terms:
Phantom Limb
Amputation, Traumatic

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail Please note that from 132 subjects enrolled, 112 started (were randomized) as 20 subjects screened out after signing the consent form (time commitment=8; loss of interest=5; no more phantom limb pain=3; personal reasons=4).
Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Period Title: Overall Study
STARTED 29 28 28 27
COMPLETED 28 24 26 25
NOT COMPLETED 1 4 2 2

Baseline Characteristics

Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy Total
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Total of all reporting groups
Overall Participants 29 28 28 27 112
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
48.24
(16.28)
39.96
(15.96)
46
(12.73)
42.96
(12.28)
44.34
(14.82)
Sex: Female, Male (Count of Participants)
Female
7
24.1%
10
35.7%
11
39.3%
10
37%
38
33.9%
Male
22
75.9%
18
64.3%
17
60.7%
17
63%
74
66.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
3.4%
1
3.6%
0
0%
0
0%
2
1.8%
Asian
0
0%
1
3.6%
1
3.6%
1
3.7%
3
2.7%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
7
24.1%
6
21.4%
6
21.4%
6
22.2%
25
22.3%
White
14
48.3%
15
53.6%
15
53.6%
15
55.6%
59
52.7%
More than one race
4
13.8%
5
17.9%
5
17.9%
5
18.5%
19
17%
Unknown or Not Reported
3
10.3%
0
0%
1
3.6%
0
0%
4
3.6%
Region of Enrollment (Count of Participants)
United States
10
34.5%
9
32.1%
10
35.7%
10
37%
39
34.8%
Brazil
19
65.5%
19
67.9%
18
64.3%
17
63%
73
65.2%
Phantom Limb Pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
6.12
(1.88)
6.29
(1.67)
6.09
(1.75)
5.90
(1.57)
6.08
(1.71)

Outcome Measures

1. Primary Outcome
Title Changes in the Visual Analog Scale for Phantom Limb Pain
Description The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Measure Participants 29 28 28 27
Mean (Standard Deviation) [units on a scale]
-2.84
(2.95)
-3.35
(3.24)
-1.78
(2.96)
-2.58
(2.78)
2. Secondary Outcome
Title Changes in the Visual Analog Scale for Stump Pain
Description The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Measure Participants 29 28 28 27
Mean (Standard Deviation) [units on a scale]
-1.31
(2.99)
-1.9
(3.99)
-0.91
(2.94)
-0.96
(2.84)
3. Secondary Outcome
Title Changes in the Visual Analog Scale for Phantom Limb Sensation
Description The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame 4 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Measure Participants 29 28 28 27
Mean (Standard Deviation) [units on a scale]
-1.86
(2.55)
-2.55
(2.64)
-1.35
(2.64)
-2.83
(3.87)

Adverse Events

Time Frame 3 months
Adverse Event Reporting Description adverse effects were collected with a questionnaire for adverse effects
Arm/Group Title Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Arm/Group Description Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation. Mirror Therapy: Sham: Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
All Cause Mortality
Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/29 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%)
Serious Adverse Events
Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/29 (0%) 0/28 (0%) 0/28 (0%) 0/27 (0%)
Other (Not Including Serious) Adverse Events
Active tDCS and Active Mirror Therapy Active tDCS and Sham Mirror Therapy Sham tDCS and Active Mirror Therapy Sham tDCS and Sham Mirrory Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/29 (24.1%) 6/28 (21.4%) 6/28 (21.4%) 6/27 (22.2%)
Skin and subcutaneous tissue disorders
Tingling sensation over stimulation area 7/29 (24.1%) 35 6/28 (21.4%) 32 6/28 (21.4%) 29 6/27 (22.2%) 30

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. Felipe Fregni
Organization Spaulding Rehabilitation Hospital
Phone 6179526158
Email fregni.felipe@mgh.harvard.edu
Responsible Party:
Felipe Fregni, MD, PhD, MPH, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT02487966
Other Study ID Numbers:
  • 2015P001065
First Posted:
Jul 2, 2015
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022