Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Status Not yet recruiting

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

Clinical Trial Details

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

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.