Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/26/2019 |
| Start Date: | April 2015 |
| End Date: | December 2017 |
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management
This study looks at the effect of combined breathing-controlled electrical stimulation
(BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after
spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of
combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the
study in a population of spinal cord injury patients. Note that this study will also enroll
healthy volunteers, brain injury patients, and amputation patients and that this study as
applied to these other populations will be covered in separate ClinicalTrials.gov records.
(BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after
spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of
combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the
study in a population of spinal cord injury patients. Note that this study will also enroll
healthy volunteers, brain injury patients, and amputation patients and that this study as
applied to these other populations will be covered in separate ClinicalTrials.gov records.
Inclusion Criteria:
- between 18 and 75 years
- male and female subjects
- has neuropathic pain after traumatic spinal cord injury
- has chronic pain, >3 months
- is stable on oral pain medications at least two weeks. (patients are allowed to
continue their pain medications, i.e., no change in pain medications.)
Exclusion Criteria:
- currently adjusting oral pain medications for their neuropathic pain
- have pain, but not neuropathic (e.g., from inflammation at the incision wound of the
residual limb or neuroma)
- have a pacemaker, or other metal and/or implanted devices
- have amputation in their arm(s)
- have spinal cord injury (SCI) involving impairment of arms
- have cognitive impairment from brain injury or are not able to follow commands, or to
give consent
- have asthma or other pulmonary disease
- are not medically stable
- have preexisting psychiatric disorders
- alcohol or drug abuse
- have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and
antidepressants.
- Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is
commonly used in the literature, will be used to screen for cognitive impairment. A
brain injury patient with a score of 24 or lower on MMSE will be excluded.
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