Status:
COMPLETED
Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management - Spinal Cord Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Pain Management
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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, amput...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03302793
Start Date
April 1 2015
End Date
December 1 2017
Last Update
January 24 2019
Active Locations (1)
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1
TIRR
Houston, Texas, United States, 77030