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

Mass General Brigham

Status: Completed

Conditions: Neuropathic Pain; Chronic Pain; Spinal Cord Injury

Treatments: Device: Transcranial direct current stimulation (tDCS)

Study type: Interventional

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

Identifiers

NCT01599767

2011-p-002353

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 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)