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Clinical Trial Summary

People with spinal cord injuries may experience muscle tightness or uncontrollable spasms. This study is being conducted to investigate whether transcutaneous spinal stimulation can improve these symptoms. Transcutaneous spinal stimulation is a non-surgical intervention by applying electrical currents using skin electrodes over the lower back and belly. The investigators want to see how well the intervention of transcutaneous spinal stimulation performs by testing different levels of stimulation pulse rates. Also, transcutaneous spinal stimulation is compared to muscle relaxants such as baclofen and tizanidine, commonly given to people with spinal cord injuries, to reduce muscle stiffness and spasms. By doing this, the investigators hope to discover if transcutaneous spinal stimulation similarly reduces muscle spasms and stiffness or if combining both methods works best. This could help improve treatment options for people with spinal cord injuries in the future.


Clinical Trial Description

The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes: - Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz. - Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen. - Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine. - Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone. Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06274021
Study type Interventional
Source University of Mississippi Medical Center
Contact Matthias J Krenn, Ph.D.
Phone 601-364-3413
Email mkrenn@umc.edu
Status Not yet recruiting
Phase Early Phase 1
Start date April 1, 2024
Completion date December 31, 2025

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