Spaulding-Harvard Spinal Cord Injury (SH-SCI) Study: Effects of tDCS on Chronic Pain in Spinal Cord Injury.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injury
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Change in Pain Scale
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Felipe Fregni
Associate Professor
Spaulding Rehabilitation Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Change in Pain Scale
Time Frame: Measured for approximately 6 months
Determine whether anodal transcranial direct current stimulation is effective in reducing pain in subjects with chronic sublesional neuropathic pain due to spinal cord injury, as measured by changes in the Brief Pain Inventory (BPI) from baseline to follow-up (up to 2 months after the final stimulation session).
Secondary Outcomes
- Changes in Quality of Life Scale(Measured for approximately 6 months)
- Changes in Mood Scale(Measured for approximately 6 months)