Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury

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

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2016-12-31

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 associated with spinal cord injury. This study is part of the Spaulding-Harvard 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- 1 week of stimulation (5 consecutive days) followed by 2 weeks of stimulation (10 consecutive days) after a 3-month follow up visit. 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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Spinal Cord Injury Chronic Pain Neuropathic Pain

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

* Over 18 years of age
* History of moderate to severe sublesional pain

Exclusion Criteria

* Active alcohol or drug dependence, as self-reported
* A history of bipolar disorder or psychosis, as self-reported
* Inability to travel to the 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 \[53\]: carbamazepine, oxcarbazepine, phenytoin, ropinirole (Requip), pramipexole (Mirapex), and cabergoline (Dostinex),
* The following contradictions to tDCS: implanted metal plates in the head, or deep brain stimulator (spinal cord implants, including baclofen pumps, are not a contraindication as cranial currents do not reach the spinal cord \[24\]).
* Pregnancy at time of enrollment
* Current use of ventilator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No