Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
University of Mississippi Medical Center
Study ID
NCT06274021
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Spinal Cord Injuries
  • Spinal Cord Injury
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury Thoracic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous spinal stimulation at 100 Hz — DEVICE
    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 100 Hz, performed at a sub-motor threshold for 30 minutes.
  • Transcutaneous spinal stimulation at 50 Hz — DEVICE
    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.
  • Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen — COMBINATION_PRODUCT
    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.
  • Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine — COMBINATION_PRODUCT
    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.
  • Sham transcutaneous spinal stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

Change from baseline of posterior root reflexes (PRRs) recruitment curves. [ Time Frame: Baseline and at post-intervention (100 minutes) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Methodist Rehabilitation CenterJacksonMississippi39216
Dobrivoje S Stokic, MD, DSc
[email protected]
601-364-3314
University of Mississippi Medical CenterJacksonMississippi39216
Matthias J Krenn, PhD
[email protected]
601-364-3413

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By research site
Methodist Rehabilitation Center· Jackson, MSUniversity of Mississippi Medical Center· Jackson, MS

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