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

Study Overview
=================
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.

Official Title
-----------------
Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.

Conditions
-----------------
Pain, Burn Injury

Intervention / Treatment
-----------------
* Device: Transcranial Direct Current Stimulation (tDCS)


Participation Criteria
=================
Eligibility Criteria
-----------------
STUDY ELIGIBILITY CRITERIA: Providing informed consent to participate in the study 18 to 64 years old 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 Use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study No contraindications to tDCS: metallic implants in the head implanted brain medical devices Subject is not pregnant at the time of enrollment 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>Subjects will undergo 20 minutes of active tDCS stimulation. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>* Other names: low intensity 1x1 direct current stimulator;|
| Sham Comparator: Sham tDCS<br>Subjects will undergo sham tDCS stimulation, where the current is only active for 30 seconds. | Device: Transcranial Direct Current Stimulation (tDCS)<br>* 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.<br>* Other names: low intensity 1x1 direct current stimulator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of tDCS on pain/itch perception | 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. | Measured for approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of tDCS on motor cortex excitability | 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. | Measured for approximately 2 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcranial Direct Current Stimulation