Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury

• Sponsor: Spaulding Rehabilitation Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01795079
• Collaborator: U.S. Department of Education (U.S. Fed)
• Enrollment: 34
• Location: 1
• Arms: 2
• Duration (Months): 87.4
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

Condition or Disease	Intervention/Treatment	Phase
Burn Injury; Chronic Pain; Pruritus; Itching	Device: Transcranial direct current stimulation (tDCS)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Boston-Harvard Burn Injury Model System: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Apr 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active tDCS Subjects will undergo 20 minutes active tDCS.	Device: Transcranial direct current stimulation (tDCS); Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.; Other Names: 1x1 low-intensity direct current stimulator Soterix Medical
Sham Comparator: Sham tDCS Subjects will undergo 20 minutes of sham stimulation.	Device: Transcranial direct current stimulation (tDCS); Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.; Other Names: 1x1 low-intensity direct current stimulator Soterix Medical

Outcome Measures

Primary Outcome Measures

1. Change in Pain Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, & current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, & general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.

2. Change in Itch Severity/Activity Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.

Secondary Outcome Measures

1. Change in Depression Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of depression in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.

2. Change in Post-Traumatic Stress Symptoms Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in decreasing post-traumatic stress symptoms in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Impact of Event Scale Revised (IES-R).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress

3. Change in Anxiety Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of anxiety in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.

Other Outcome Measures

1. Change in Quality of Life Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Veterans RAND 36 Item Health Survey (VR-36). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.

2. Change in Community Integration Scale [2 weeks]

   Determine whether anodal transcranial direct current stimulation is effective in increasing community integration functional outcomes in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Community Integration Questionnaire (CIQ). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Providing informed consent to participate in the study

• Age 18 or older

• Burn injury with pain and/or itch that is moderate to severe

• Burn injury occurring at least 3 weeks prior to enrollment

Exclusion Criteria:

• Subjects with burns in scalp in the area of electrode placement

• Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality

• Learning disorders that may prevent patient's ability to complete assessments

• Unstable conditions preventing travel to study site

• Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin

• Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices

• Pregnancy at time of enrollment

• History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)

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
• U.S. Department of Education

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 21, 2016

More Information

Additional Information:

• Boston-Harvard Burn Injury Model System Website

Publications

None provided.

• Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT01795079
• Other Study ID Numbers: 2012-p-001996
• First Posted: Feb 20, 2013
• Last Update Posted: Mar 17, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital: transcranial stimulation; direct current
• Additional relevant MeSH terms: Pruritus; Chronic Pain; Wounds and Injuries; Burns

Study Results

Participant Flow

Pre-assignment Detail	Please note that 34 subjects consented to participated but 3 were screened out (after consent, there are additional tests to determine eligibility) and/or they dropped out before randomization (therefore, only 31 subjects were randomized).

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Period Title: Overall Study
STARTED	16	15
COMPLETED	13	12
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Active tDCS	Sham tDCS	Total
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Total of all reporting groups
Overall Participants	16	15	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49 (14)	48 (14)	48.5 (14)
Sex: Female, Male (Count of Participants)
Female	9 56.3%	7 46.7%	16 51.6%
Male	7 43.8%	8 53.3%	15 48.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 6.3%	1 6.7%	2 6.5%
Not Hispanic or Latino	15 93.8%	14 93.3%	29 93.5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Pain Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with neuropathic pain due to burn injury, as measured by changes in the Brief Pain Inventory (BPI). Brief Pain Inventory (BPI) consist consists of a 9 part questionnaire. The questions include the severity of pain levels (worst, least, average, & current), the impact of pain on daily functioning in different areas (mood, walking, relationships, sleep, normal work, & general activity), current treatments and perceived effectiveness of current treatments. The VAS Pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine'') measuring patients' worst pain and least pain, on average and at present time.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

blinded assessment of scores at the primary endpoint (2 weeks)

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	4.45 (1.94)	4.19 (1.45)

2. Primary Outcome

Title	Change in Itch Severity/Activity Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in reducing itch severity/activity in subjects with neuropathic itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS) .This is a 0 to 10 scale, where 0 indicates no intensity and a 10 indicates unbearable intensity of itching.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

blinded assessment at primary endpoint (2 weeks)

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	3.65 (2.91)	1.83 (1.76)

3. Secondary Outcome

Title	Change in Depression Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of depression in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Beck Depression Inventory (BDI). The Beck Depression Inventory (BDI) contains 21 questions, each answer being scored on a scale value of 0 to 3 (total from 0-63). Higher total scores indicate more severe depressive symptoms.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

blinded assessment of scores at the primary endpoint (2 weeks)

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Measure Participants	13	12
Mean (Standard Deviation) [score on a scale]	9.1 (7.1)	9.2 (7.8)

4. Secondary Outcome

Title	Change in Post-Traumatic Stress Symptoms Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in decreasing post-traumatic stress symptoms in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Impact of Event Scale Revised (IES-R).This 22-item scale is designed to measure severity of PTS symptoms associated with a traumatic event. Subjects rate their level of distress associated with the event on a 0-4 scale (0 means not at all distressed, 4 means extremely distressed). The IES-R yields a total score (ranging from 0 to 88) where higher scores represent higher stress
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

blinded assessment of scores at the primary endpoint(2 weeks)

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Measure Participants	13	12
Mean (Standard Deviation) [score on a scale]	10.8 (10.6)	36.3 (16.5)

5. Secondary Outcome

Title	Change in Anxiety Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in decreasing severity of anxiety in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Visual Analog Scale (VAS).This is a self-evaluation scale that ranges from 0 to 10, where 0 means no anxiety and 10 means the worst anxiety ever.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

blinded assessment at the primary endpoint (2 weeks)

Arm/Group Title	Active tDCS	Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.	Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Measure Participants	13	12
Mean (Standard Deviation) [units on a scale]	3.25 (3.62)	2.92 (3.37)

6. Other Pre-specified Outcome

Title	Change in Quality of Life Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Veterans RAND 36 Item Health Survey (VR-36). There are eight domains total including: bodily pain, role limitations due to physical problems, physical functioning, general health perception, vitality, social functioning, and role limitations due to mental health issues. Scores for each domain are from 0-100 with a higher score defining a more favorable health outcome.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

Title	Change in Community Integration Scale
Description	Determine whether anodal transcranial direct current stimulation is effective in increasing community integration functional outcomes in subjects with neuropathic pain and itching due to burn injury, as measured by changes in the Community Integration Questionnaire (CIQ). Total CIQ scores were used as the outcome measure. Contains 15 itms assessing community integrations across three domains (Home integration, social integration, productive activity) . The total score can range from 0 to 29 points (0 - minimal integration to 29 -maximal integration). A positive change indicates an improvement in integration.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Period of stimulation (3 weeks)
Arm/Group Title	Active tDCS		Sham tDCS
Arm/Group Description	Subjects will undergo 20 minutes active tDCS. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.		Subjects will undergo 20 minutes of sham stimulation. Transcranial direct current stimulation (tDCS): Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
All Cause Mortality
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Serious Adverse Events
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Active tDCS		Sham tDCS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)		5/15 (33.3%)
Nervous system disorders
Hedache	2/16 (12.5%)	2	5/15 (33.3%)	9

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.