Burn Injury, Chronic Pain, Itching, Pruritus
Conditions
Keywords
transcranial stimulation, direct current
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.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Sponsors
U.S. Department of Education
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 15 |
| Total | 31 |
Baseline characteristics
| Characteristic | Active tDCS | Sham tDCS | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 14 | 48.5 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 2 / 16 | 5 / 15 |
| serious Total, serious adverse events | 0 / 16 | 0 / 15 |
Outcome results
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.
Time frame: 2 weeks
Population: blinded assessment at primary endpoint (2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Itch Severity/Activity Scale | 3.65 units on a scale | Standard Deviation 2.91 |
| Sham tDCS | Change in Itch Severity/Activity Scale | 1.83 units on a scale | Standard Deviation 1.76 |
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.
Time frame: 2 weeks
Population: blinded assessment of scores at the primary endpoint (2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Pain Scale | 4.45 units on a scale | Standard Deviation 1.94 |
| Sham tDCS | Change in Pain Scale | 4.19 units on a scale | Standard Deviation 1.45 |
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.
Time frame: 2 weeks
Population: blinded assessment at the primary endpoint (2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Anxiety Scale | 3.25 units on a scale | Standard Deviation 3.62 |
| Sham tDCS | Change in Anxiety Scale | 2.92 units on a scale | Standard Deviation 3.37 |
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.
Time frame: 2 weeks
Population: blinded assessment of scores at the primary endpoint (2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Depression Scale | 9.1 score on a scale | Standard Deviation 7.1 |
| Sham tDCS | Change in Depression Scale | 9.2 score on a scale | Standard Deviation 7.8 |
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
Time frame: 2 weeks
Population: blinded assessment of scores at the primary endpoint(2 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Post-Traumatic Stress Symptoms Scale | 10.8 score on a scale | Standard Deviation 10.6 |
| Sham tDCS | Change in Post-Traumatic Stress Symptoms Scale | 36.3 score on a scale | Standard Deviation 16.5 |
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.
Time frame: 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.
Time frame: 2 weeks