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| Name | Class |
|---|---|
| U.S. Department of Education | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Subjects will undergo 20 minutes active tDCS. |
|
| Sham tDCS | Sham Comparator | Subjects will undergo 20 minutes of sham stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Device | Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Scale | 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 weeks |
| Change in Itch Severity/Activity Scale | 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depression Scale | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Scale | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD PhD MPH | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02129 | United States |
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| Label | URL |
|---|---|
| Boston-Harvard Burn Injury Model System Website | View source |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham tDCS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Scale | 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. | blinded assessment of scores at the primary endpoint (2 weeks) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
Period of stimulation (3 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hedache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Felipe Fregni | Spaulding Rehabilitation Hospital | 6179526158 | fregni.felipe@mhg.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2016 | Feb 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002056 | Burns |
| D059350 | Chronic Pain |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| 2 weeks |
| Change in Post-Traumatic Stress Symptoms Scale | 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 | 2 weeks |
| Change in Anxiety Scale | 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. | 2 weeks |
| 2 weeks |
| Change in Community Integration Scale | 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. | 2 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | 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.
| OG001 | 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. |
|
|
| Primary | Change in Itch Severity/Activity Scale | 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. | blinded assessment at primary endpoint (2 weeks) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Change in Depression Scale | 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. | blinded assessment of scores at the primary endpoint (2 weeks) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | Change in Post-Traumatic Stress Symptoms Scale | 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 | blinded assessment of scores at the primary endpoint(2 weeks) | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
|
| Secondary | Change in Anxiety Scale | 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. | blinded assessment at the primary endpoint (2 weeks) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Other Pre-specified | Change in Quality of Life Scale | 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. | Not Posted | 2 weeks | Participants |
| Other Pre-specified | Change in Community Integration Scale | 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. | Not Posted | 2 weeks | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | 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. | 0 | 15 | 0 | 15 | 5 | 15 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |