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

NCT01404026 | Completed

• 1 other identifier: 2010-p-001209
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Burn Injury

Keywords

Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of tDCS on motor cortex excitability

  Measured for approximately 2 weeks.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Subjects will undergo 20 minutes of active tDCS stimulation.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Subjects will undergo sham tDCS stimulation, where the current is only active for 30 seconds.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: low intensity 1x1 direct current stimulator

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pain; Burns

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital (SRH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 27, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)