Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Study Details
Study Description
Brief Summary
This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: tDCS intervention (open label) Subjects will undergo tDCS stimulation |
Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)
Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
|
Outcome Measures
Primary Outcome Measures
- Pain as Measured by the Visual Analog Scale [Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)]
The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to provide informed consent to participate in the study.
-
Subject is older than 18 years.
-
3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
-
Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
-
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:
-
Pregnancy or trying to become pregnant in the next 2 months.
-
History of alcohol or drug abuse within the past 6 months as self-reported.
-
Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
-
Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
-
Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
-
Uncontrolled Epilepsy
-
Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
-
History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
-
History of neurosurgery, as self-reported.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Spaulding Rehabilitation Hospital | Boston | Massachusetts | United States | 02129 |
Sponsors and Collaborators
- Spaulding Rehabilitation Hospital
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- 2015P002525
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | tDCS Intervention (Open Label) |
|---|---|
| Arm/Group Description | Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period. |
| Period Title: Overall Study | |
| STARTED | 9 |
| COMPLETED | 5 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | tDCS Intervention (Open Label) |
|---|---|
| Arm/Group Description | Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period. |
| Overall Participants | 9 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
7
77.8%
|
| >=65 years |
2
22.2%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
54.6
(16.58)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
4
44.4%
|
| Male |
5
55.6%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
11.1%
|
| White |
8
88.9%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| United States |
9
100%
|
Outcome Measures
| Title | Pain as Measured by the Visual Analog Scale |
|---|---|
| Description | The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain. |
| Time Frame | Change in outcome from baseline to 2-week follow-up (after the last day of stimulation) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | tDCS Intervention (Open Label) |
|---|---|
| Arm/Group Description | Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period. |
| Measure Participants | 9 |
| Mean (Standard Deviation) [units on a scale] |
-1.4
(1.14)
|
Adverse Events
| Time Frame | 2 weeks | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | tDCS Intervention (Open Label) | |
| Arm/Group Description | Subjects will undergo tDCS stimulation transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period. | |
All Cause Mortality |
||
| tDCS Intervention (Open Label) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Serious Adverse Events |
||
| tDCS Intervention (Open Label) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| tDCS Intervention (Open Label) | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Prof. Felipe Fregni |
|---|---|
| Organization | Spaulding Rehabilitation Hospital |
| Phone | +1 (617) 935-2743 |
| Fregni.Felipe@mgh.harvard.edu |
- 2015P002525