Recruiting

Early Phase 1

NeuromodulationNeuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Sponsor:

University of Mississippi Medical Center

Code:

NCT06274021

Conditions

Spinal Cord Injuries

Spinal Cord Injury

Spinal Cord Injury Cervical

Spinal Cord Injury Thoracic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous spinal stimulation at 100 Hz

Transcutaneous spinal stimulation at 50 Hz

Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen

Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine

Sham transcutaneous spinal stimulation

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Spinal Cord Injury

Spinal Cord Injury Cervical

Spinal Cord Injury Thoracic

Study ID

NCT06274021

Start date

Mar 1, 2024

Status verified date

Jun, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

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

Exclusion criteria:

Neurological level of spinal cord injury below T11
Ventilatory-dependent
Change in neurological status over the past 2 months
Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
Systolic blood pressure at rest lower than 90 mm Hg
Implanted active devices (e.g., intrathecal baclofen pumps)
Passive implants (plates, screws) between T11 and L2 vertebras
Skin conditions precluding placement of electrodes
Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
Receiving antibiotics for infections
Pregnancy
Difficulty following instructions
Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study
Other medical risks/contraindications as determined by the study physicians

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

Transcutaneous spinal stimulation at 100 Hz

Transcutaneous spinal stimulation at 50 Hz

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.

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.

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.

Primary outcome measure

Change from baseline of posterior root reflexes (PRRs) recruitment curves. [ Time Frame: Baseline and at post-intervention (100 minutes) ]
Change from baseline of flexion withdrawal reflex (FWR) response amplitude. [ Time Frame: Baseline and at post-intervention (100 minutes) ]
Change from baseline of stretch reflex (SR) response amplitude. [ Time Frame: Baseline and at post-intervention (100 minutes) ]
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS), [ Time Frame: Baseline and at post-intervention (100 minutes) ]
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). [ Time Frame: Baseline and at post-intervention (100 minutes) ]

Central Contacts and Locations

Central contacts

Matthias J Krenn, Ph.D.

601-364-3413 mkrenn@umc.edu

Dobrivoje S Stokic, M.D., D.Sc.

601-364-3314 dstokic@mmrcrehab.org

Locations

Methodist Rehabilitation Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Dobrivoje S Stokic, MD, DSc

601-364-3314 dstokic@mmrcrehab.org

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Matthias J Krenn, PhD

601-364-3413 mkrenn@umc.edu

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

Jul 1, 2024

Last verified

Jun, 2024

Keywords

Spinal Cord Injury
Neuromodulation
Electrical Stimulation
Spinal Cord Stimulation
Spasticity
Transcutaneous Spinal Stimulation
Lower extremity
Transcutaneous spinal cord stimulation
Paralysis
Spinal reflex

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2024-07-01.