Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    22
  • sponsor
    The University of Texas Health Science Center, Houston
Updated on 25 January 2021
electrical stimulation
spasticity
spinal cord
nervous
spinal cord disorder
paraplegia

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 patients.

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 stroke patients.10 Most similar to our TINS protocol is transcutaneous tibial nerve stimulation (TTNS), which has shown to mitigate the development of neurogenic bladder in acute SCI.6 However, neuromodulation is rarely performed in acute SCI, and, to our knowledge, neuromodulation has not been performed to prevent the development of chronic neuropathic pain. There has been little published regarding the effects of electric stimulation upon the trunk in acute SCI as a prevention for chronic neuropathic pain and spasticity. Gaps in the knowledge which we intend to fill are:

  1. Safety and feasibility of TINS in acute SCI during inpatient rehabilitation.
  2. Effectiveness of a 2-week TINS protocol in acute SCI based on changes between admission, discharge, and weekly numerical pain scores and spasticity questionnaire scores in those with TINS compared to sham TINS for 2-months.
  3. Analysis of neuropathic pain medication dosages in those with and without TINS at admission, discharge, and 2 months post-discharge, and evaluation of morbidity at 2- months post-discharge

Details
Condition Spinal Cord Injury, Peripheral Neuropathy, Neuralgia, Pain, Post-Surgical Pain, Pain (Pediatric), Spinal Cord Injuries, neuropathic pain
Treatment Sham protocol, TINS Active protocol
Clinical Study IdentifierNCT04506099
SponsorThe University of Texas Health Science Center, Houston
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute tSCI paraplegia within 4 weeks of injury (n=22)
-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 Criteria

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
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