Chronic Pain, Neuropathic Pain, Spinal Cord Injury
Conditions
Keywords
transcranial stimulation, direct current
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.
Interventions
DEVICETranscranial direct current stimulation (tDCS)
Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
Sponsors
U.S. Department of Education
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in Quality of Life Scale | Measured for approximately 6 months | Determine whether anodal transcranial direct current stimulation is effective in increasing quality of life in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Satisfaction with Life Scale (SWLS), from baseline to follow-up (up to 2 months after the final stimulation session). |
| Changes in Mood Scale | Measured for approximately 6 months | Determine whether anodal transcranial direct current stimulation is effective in improving mood in subjects with chronic neuropathic sublesional pain due to spinal cord injury, as measured by changes in the Patient Health Questionnaire-9 (PHQ9), from baseline to follow-up (up to 2 months after the final stimulation session). |
Countries
United States
Outcome results
None listed