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

NCT ID: NCT01404026

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active tDCS

Subjects will undergo 20 minutes of active tDCS stimulation.

Group Type ACTIVE_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type 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.

Sham tDCS

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

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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low intensity 1x1 direct current stimulator

Eligibility Criteria

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Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spaulding Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Felipe Fregni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felipe Fregni, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital (SRH)

Locations

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Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2010-p-001209

Identifier Type: -

Identifier Source: org_study_id

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