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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Burn Injury
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active tDCS; Subjects will undergo 20 minutes of active tDCS stimulation.	Device: Transcranial 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.; Other Names: low intensity 1x1 direct current stimulator
Sham Comparator: Sham tDCS; Subjects will undergo sham tDCS stimulation, where the current is only active for 30 seconds.	Device: Transcranial 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.; 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.

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: July 26, 2011
• First Posted (Estimate): July 27, 2011

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 23, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Transcranial Direct Current Stimulation
• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: 2010-p-001209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No