Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Combination product, Device
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• History of spinal cord injury

• Time since diagnosis longer than six months

• Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity \[range from 0 to 10\])

• If needed, agreement to reduce antispastic medication

Locations
United States
Mississippi
Methodist Rehabilitation Center
RECRUITING
Jackson
University of Mississippi Medical Center
RECRUITING
Jackson
Contact Information
Primary
Matthias J Krenn, Ph.D.
mkrenn@umc.edu
601-364-3413
Backup
Dobrivoje S Stokic, M.D., D.Sc.
dstokic@mmrcrehab.org
601-364-3314
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 16
Treatments
Experimental: Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo
Each participant will receive five distinct interventions:~* Transcutaneous spinal stimulation at 100 Hz for 30 minutes with a placebo~* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a placebo~* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose baclofen~* Transcutaneous spinal stimulation at 50 Hz for 30 minutes with a single-dose tizanidine~* Transcutaneous spinal stimulation (sham) for 30 minutes with a placebo
Related Therapeutic Areas
Sponsors
Collaborators: Methodist Rehabilitation Center, The Craig H. Neilsen Foundation
Leads: University of Mississippi Medical Center

This content was sourced from clinicaltrials.gov