Burn Injury, Pain
Conditions
Keywords
Transcranial Direct Current Stimulation
Brief summary
The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on the neuropathic symptoms (pain/itch) due to a burn injury. The investigators hypothesize that the active tDCS group will show a significant pain/itch reduction when compared to sham stimulation.
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
Subjects will undergo tDCS stimulation. For both active and sham stimulation we will use electrodes at 35cm\^2, with an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex, and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be active for the duration of 20 minutes. For sham stimulation, the current will only be active for 30 seconds, simulating the sensations of active stimulation.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
STUDY ELIGIBILITY CRITERIA: 1. Providing informed consent to participate in the study 2. 18 to 64 years old 3. Any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study. \- Subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries 4. Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study 5. No contraindications to tDCS: * metallic implants in the head * implanted brain medical devices 6. Subject is not pregnant at the time of enrollment 7. Neuropathic pain or itching (rated at least 4 on the VAS) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks. Please note: If a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of tDCS on pain/itch perception | Measured for approximately 2 weeks | Determine whether active tDCS offers a greater benefit on pain reduction in patients with neuropathic symptoms (itch/pain) following burns as compared with sham tDCS. We hypothesize that active tDCS will be associated with a larger pain/itch reduction, as indexed by the Visual Analogue Scale for Pain/Itch (VAS). The subject's VAS score will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of tDCS on motor cortex excitability | Measured for approximately 2 weeks. | To investigate whether active tDCS induces changes in motor cortex and spinal cord excitability as indexed by single and paired-pulse transcranial magnetic stimulation (TMS) as compared with sham tDCS. We will also determine whether these changes are correlated with the clinical outcome (pain/itch reduction). The subject's cortical excitability will be measured immediately before the tDCS stimulation sessions and after the tDCS stimulation sessions for the duration of their participation in the trial. |
Countries
United States
Outcome results
None listed