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Transcutaneous Intercostal Nerve Stimulation in Spinal Cord Injury

NCT04506099 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-22

No results posted yet for this 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.

Conditions

  • Neuropathic Pain
  • SCI - Spinal Cord Injury

Interventions

DEVICE

TINS Active protocol

Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect, verified with contraction of the rectus abdominis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.

DEVICE

Sham protocol

Electrical stimulation will be applied to the T6-T11 levels of intercostal nerves, as close to the level directly below the level of injury as possible until contraction is seen in the rectus abdominis. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used. Electrodes 2 inch by 4 inch will be placed according to anatomic landmarks with the negative electrode applied to the lateral ribcage and the positive electrode applied to the ventral aspect. The intensity level will be set to 1mA . If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Argyrios Stampas, MD · UTHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2021-09-30
Completion
2021-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04506099 on ClinicalTrials.gov