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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01404026
First received: June 29, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Burn Injury
 Device: Transcranial Direct Current Stimulation (tDCS)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Effect of tDCS on pain/itch perception [ Time Frame: Measured for approximately 2 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Effect of tDCS on motor cortex excitability [ Time Frame: Measured for approximately 2 weeks. ] [ Designated as safety issue: No ]
    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.


Enrollment: 3
Study Start Date: June 2011
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: low intensity 1x1 direct current stimulator

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404026

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital (SRH)
  More Information

No publications provided

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01404026     History of Changes
Other Study ID Numbers: 2010-p-001209
Study First Received: June 29, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Spaulding Rehabilitation Hospital:
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013