Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation

University of Mississippi Medical Center

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.

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 Cent…

Eligibility

Age range: 18+ years

Interventions

Device

Transcutaneous spinal stimulation at 100 Hz

Device

Transcutaneous spinal stimulation at 50 Hz

Combination Product

Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen

Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes. Study participants will receive a single dose of baclofen, a centrally-acting muscle relaxant belonging to the class of gamma-aminobutyric acid (GABA) analogs. Its primary mechanism involves acting on the GABA receptors in the brain and spinal cord to decrease spasticity. Participants will receive baclofen orally at a single dose of 10 mg.

Combination Product

Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine

Transcutaneous spinal stimulation (TSS) is a non-invasive neuromodulation method that uses electrical currents to stimulate sensory fibers. The procedure involves placing surface electrodes midline on the lower back (T11-12 spinal processes) and on each side of the belly button. The stimulation frequency during the intervention is 50 Hz, performed at a sub-motor threshold for 30 minutes. Study participants will receive a medication called tizanidine, which is an alpha-2 adrenergic agonist. This medication works by inhibiting presynaptic motor neurons, resulting in a reduction of muscle spasticity. It is commonly used to manage spasticity caused by neurological disorders. Each participant will be given a single oral dose of 4 mg of tizanidine as part of this trial.

Device

Sham transcutaneous spinal stimulation

Sham Transcutaneous spinal stimulation (TSS) involves placing two surface electrodes midline on the lower back (T11-12 spinal processes). The stimulation frequency during the intervention is 50 Hz, performed for 30 minutes.

Summary

Description

Eligibility

Interventions

Locations (2)