Trial Outcomes & Findings for Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury (NCT NCT01795079)
NCT ID: NCT01795079
Last Updated: 2021-03-17
Results Overview
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.
COMPLETED
NA
34 participants
2 weeks
2021-03-17
Participant Flow
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).
Participant milestones
| Measure |
Active tDCS
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.
|
Sham tDCS
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.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury
Baseline characteristics by cohort
| Measure |
Active tDCS
n=16 Participants
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.
|
Sham tDCS
n=15 Participants
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
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 14 • n=5 Participants
|
48 years
STANDARD_DEVIATION 14 • n=7 Participants
|
48.5 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: blinded assessment of scores at the primary endpoint (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.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
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.
|
Sham tDCS
n=12 Participants
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.
|
|---|---|---|
|
Change in Pain Scale
|
4.45 units on a scale
Standard Deviation 1.94
|
4.19 units on a scale
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: blinded assessment at primary endpoint (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.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
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.
|
Sham tDCS
n=12 Participants
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.
|
|---|---|---|
|
Change in Itch Severity/Activity Scale
|
3.65 units on a scale
Standard Deviation 2.91
|
1.83 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: blinded assessment of scores at the primary endpoint (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.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
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.
|
Sham tDCS
n=12 Participants
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.
|
|---|---|---|
|
Change in Depression Scale
|
9.1 score on a scale
Standard Deviation 7.1
|
9.2 score on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: blinded assessment of scores at the primary endpoint(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
Outcome measures
| Measure |
Active tDCS
n=13 Participants
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.
|
Sham tDCS
n=12 Participants
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.
|
|---|---|---|
|
Change in Post-Traumatic Stress Symptoms Scale
|
10.8 score on a scale
Standard Deviation 10.6
|
36.3 score on a scale
Standard Deviation 16.5
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: blinded assessment at the primary endpoint (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.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
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.
|
Sham tDCS
n=12 Participants
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.
|
|---|---|---|
|
Change in Anxiety Scale
|
3.25 units on a scale
Standard Deviation 3.62
|
2.92 units on a scale
Standard Deviation 3.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksDetermine 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksDetermine 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.
Outcome measures
Outcome data not reported
Adverse Events
Active tDCS
Sham tDCS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=16 participants at risk
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.
|
Sham tDCS
n=15 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Hedache
|
12.5%
2/16 • Number of events 2 • Period of stimulation (3 weeks)
|
33.3%
5/15 • Number of events 9 • Period of stimulation (3 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place