Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Last updated: October 15, 2021
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Trial Not Available

Phase

N/A

Condition

Chronic Pain

Acute Pain

Pain

Treatment

N/A

Clinical Study ID

NCT04506099
HSC-MS-20-0048
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

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 inthe 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, degenerativediseases 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

Study Design

Study Start date:
July 17, 2020
Estimated Completion Date:
November 30, 2021

Study 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

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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