Spaulding-Harvard Model System: Effects of Transcranial Direct Current Stimulation (tDCS) on Chronic Pain in Spinal Cord Injury
Completed · Not applicable · Has a placebo group
Conditions studied: Spinal Cord Injury, Chronic Pain, Neuropathic Pain
In brief
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.
Key facts
- Study ID
- NCT01599767
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 46
- Starts
- 2011-12-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2020-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Over 18 years of age
- History of moderate to severe sublesional pain
You may not qualify if…
- 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.
Where it is running
- Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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