Status:
WITHDRAWN
Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Neuropathic Pain
SCI - Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety, feasibility, and effectiveness of electric stimulation of the nerves along the intercostal nerves on pain and spasticity in spinal cord injury pat...
Detailed Description
Neuromodulation techniques are safely used as a treatment for neuropathic pain in chronic SCI. Neuromodulation techniques have also been safely and successfully used to strengthen the abdomen in strok...
Eligibility Criteria
Inclusion
- Acute tSCI paraplegia within 4 weeks of injury (n=22)
- 18-75 years old
- Neurologic levels T1-T10
- English speaking
- Admitted to TIRR with pain medications
- TINS can elicit visible or palpable abdominal muscle contraction
Exclusion
- Subjects with pacemakers, defibrillators, insulin pumps, and similar devices
- History of peripheral neuropathy
- History of premorbid symptoms of peripheral neuropathy (numbness and/or tingling in the lower extremities, sharp/jabbing/burning pain in the lower extremities, sensitivity to touch, lack of coordination, lack of sensation, muscle weakness, etc.)
- History of nervous system disorder (i.e. prior SCI, stroke, brain injury, degenerative diseases such as Parkinson's disease, etc.)
- Ventilator dependent respiration
- Inability to speak
- Non-English speakers
- Pregnancy
- History of chronic pain
- Intolerant to electric stimulation
- Intolerant to the trial sessions
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04506099
Start Date
July 17 2020
End Date
November 30 2021
Last Update
October 22 2021
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030