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

• ClinicalTrials.gov Identifier: NCT01404026
• Recruitment Status: Completed
• First Posted: July 27, 2011
• Last Update Posted: April 24, 2020
• Sponsor: Spaulding Rehabilitation Hospital
• Information provided by (Responsible Party): Felipe Fregni, Spaulding Rehabilitation Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Burn Injury	Device: Transcranial Direct Current Stimulation (tDCS)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Cortical Modulation With Transcranial Direct Current Stimulation (tDCS) for Neuropathic Symptoms Following Burn Injury.
• Study Start Date: June 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2012

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Effect of tDCS on pain/itch perception [ Time Frame: 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 Outcome Measures :

1. Effect of tDCS on motor cortex excitability [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT01404026
• Other Study ID Numbers: 2010-p-001209
• First Posted: July 27, 2011
• Last Update Posted: April 24, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:

Transcranial Direct Current Stimulation

Additional relevant MeSH terms:

Wounds and Injuries; Burns