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 range

18 Years – 75 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years – 75 Years

Sex

ALL

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