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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2020-04-15

Brief Summary

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The purpose of this study is to see the effects of transcranial direct current stimulation (tDCS) on the pain and itching associated with burn injury. This study is part of the Boston-Harvard Burn Model System. The investigators hypothesize that there will be a decrease in pain levels with active stimulation, when compared to sham stimulation, using a 3 week stimulation schedule- 2 weeks of stimulation (10 consecutive days) followed by 1 week of stimulation (5 consecutive days) after three follow up visits at 2, 4 and 8 weeks after initial course of stimulation. The subject will also have follow ups at 2, 4 and 8 weeks after the second course of stimulation.

If a subject receives sham during the experiment, he/she may enroll in an open-label portion of the study and receive 10 days of active stimulation.

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Detailed Description

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Conditions

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Burn Injury Chronic Pain Pruritus Itching

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active tDCS

Subjects will undergo 20 minutes active tDCS.

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Sham tDCS

Subjects will undergo 20 minutes of sham stimulation.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Interventions

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Transcranial direct current stimulation (tDCS)

Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.

Intervention Type DEVICE

Other Intervention Names

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1x1 low-intensity direct current stimulator Soterix Medical

Eligibility Criteria

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Inclusion Criteria

* Providing informed consent to participate in the study
* Age 18 or older
* Burn injury with pain and/or itch that is moderate to severe
* Burn injury occurring at least 3 weeks prior to enrollment

Exclusion Criteria

* Subjects with burns in scalp in the area of electrode placement
* Psychiatric disorders that have led to hospitalization within the past 6 months or signs of suicidality
* Learning disorders that may prevent patient's ability to complete assessments
* Unstable conditions preventing travel to study site
* Current use of any of the following anti-epileptic medications or dopaminergic medications known to reduce or inhibit the benefits of tDCS treatment: carbamazepine, oxcarbazepine, phenytoin
* Contraindications to tDCS including implanted metal plates in the head or implanted brain medical devices
* Pregnancy at time of enrollment
* History of other neurological conditions associated with structural anatomical changes (i.e. stroke, brain injury, Parkinson's)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No