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

Mass General Brigham

Status: Completed

Conditions: Itching; Chronic Pain; Burn Injury; Pruritus

Treatments: Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01795079

2012-p-001996

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Active tDCS

Experimental group

Description:

Subjects will undergo 20 minutes active tDCS.

Treatment:

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

Sham Comparator group

Description:

Subjects will undergo 20 minutes of sham stimulation.

Treatment:

Device: Transcranial direct current stimulation (tDCS)