Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
- Conditions
- Spinal Cord Injury ThoracicSpinal Cord Injury CervicalSpinal Cord InjuriesSpinal Cord Injury
- Interventions
- Device: Transcutaneous spinal stimulation at 100 HzDevice: Transcutaneous spinal stimulation at 50 HzCombination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofenCombination Product: Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidineDevice: Sham transcutaneous spinal stimulation
- Registration Number
- NCT06274021
- Lead Sponsor
- University of Mississippi Medical Center
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo Transcutaneous spinal stimulation at 100 Hz 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 Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine 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 Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo Transcutaneous spinal stimulation at 50 Hz 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 Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo Sham transcutaneous spinal stimulation 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 Transcutaneous spinal stimulation in combination of baclofen/tizanidine/placebo Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen 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 Measures
Name Time Method Change from baseline of posterior root reflexes (PRRs) recruitment curves. Baseline and at post-intervention (100 minutes) Change in area under the recruitment curve of PRRs after the intervention compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Change from baseline of flexion withdrawal reflex (FWR) response amplitude. Baseline and at post-intervention (100 minutes) Change in the amplitude of the FWR response after the intervention compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Change from baseline in muscle stiffness as measured by the Modified Ashworth Scale (MAS), Baseline and at post-intervention (100 minutes) Change in cumulative scores of Modified Ashworth Scale in bilaterally five lower extremity muscles (score range: 0 to 40, where higher scores denote worsening outcomes) before and after the 30-minute intervention. The Modified Ashworth Scale is a clinically validated tool that measures resistance during passive soft-tissue stretching and indicates spasticity.
Change from baseline in spasms as measured by the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS). Baseline and at post-intervention (100 minutes) Change in the cumulative score of the Spinal Cord Assessment Tool for Spastic Reflexes, encompassing clonus, flexor spasms, and extensor spasms bilaterally, with a scoring range from 0 to 18, where higher scores denote worsening outcomes. The Spinal Cord Assessment Tool for Spastic Reflexes is a clinical tool designed to evaluate spastic reflexes in individuals with spinal cord injury specifically. It quantitatively measures the severity and pattern of spasticity by assessing involuntary muscle contractions in response to external stimuli.
Change from baseline of stretch reflex (SR) response amplitude. Baseline and at post-intervention (100 minutes) Change in the amplitude of the SR response after the intervention compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
- Secondary Outcome Measures
Name Time Method Change from baseline of flexion withdrawal reflex (FWR) response amplitude. Baseline and at during transcutaneous spinal stimulation (80 minutes) Change in the amplitude of the FWR response during transcutaneous spinal stimulation compared to the baseline. The reflex response indicates neural circuitry function and spasticity in individuals with neurological conditions. It is measured by eliciting a motor response through a standardized electrical stimulus and quantifying the change in muscle activity.
Change from baseline of stretch reflex (SR) response amplitude. Baseline and at during transcutaneous spinal stimulation (80 minutes) Change in the amplitude of the SR response during transcutaneous spinal stimulation compared to the baseline. The reflex response indicates spasticity and muscle tone in participants with neurological disorders. The amplitude of the reflex response reflects the muscle's reaction to stretch.
Change from baseline of posterior root reflexes (PRRs) recruitment curves. Baseline and at during transcutaneous spinal stimulation (80 minutes) Change in area under the recruitment curve of PRRs during transcutaneous spinal stimulation compared to the baseline. These reflexes are elicited by transcutaneous spinal stimulation and recorded in key muscles of the lower extremities.
Trial Locations
- Locations (2)
Methodist Rehabilitation Center
🇺🇸Jackson, Mississippi, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States