WithdrawnNot Applicable

Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

Stopped: Lack of study staff

United States0Started 2020-07-17

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 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

What they're measuring

Number of participants with morbidity as measured by infections

Timeframe: Admission

Number of participants with morbidity as measured by infections

Timeframe: 4-weeks post injury

Number of participants with morbidity as measured by infections

Timeframe: 2-month follow-up

Number of participants with morbidity as measured by burns.

Timeframe: Admission

Number of participants with morbidity as measured by burns.

Timeframe: 4-weeks post injury

Number of participants with morbidity as measured by burns.

Timeframe: 2-month follow-up

Number of participants with morbidity as measured by urgent transfers.

Timeframe: Admission

Number of participants with morbidity as measured by urgent transfers.

Timeframe: 4-weeks post injury

Trial details

NCT IDNCT04506099

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Neuropathic Pain trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with morbidity as measured by infections

Timeframe: Admission

Number of participants with morbidity as measured by infections

Timeframe: 4-weeks post injury

Number of participants with morbidity as measured by infections

Timeframe: 2-month follow-up

Number of participants with morbidity as measured by burns.

Timeframe: Admission

Number of participants with morbidity as measured by burns.

Timeframe: 4-weeks post injury

Number of participants with morbidity as measured by burns.

Timeframe: 2-month follow-up

Number of participants with morbidity as measured by urgent transfers.

Timeframe: Admission

Number of participants with morbidity as measured by urgent transfers.

Timeframe: 4-weeks post injury