Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
This study is investigating a non-surgical method called transcutaneous spinal stimulation (TSS) to reduce muscle stiffness and spasms in people with spinal cord injuries. TSS uses electrical currents applied through skin electrodes on the lower back and belly. Researchers are comparing different levels of TSS (100 Hz and 50 Hz) and also testing TSS at 50 Hz alone and in combination with common muscle relaxants, baclofen and tizanidine. The goal is to see if TSS can reduce muscle stiffness and spasms and change spinal reflexes. You may be able to join if you are 18 or older, have a spinal cord injury for over six months, and experience lower limb spasticity. The study status is currently unclear.
- Study design
- This interventional study plans to enroll 16 participants. It compares different frequencies of transcutaneous spinal stimulation and combinations with medications.
- What's involved
- You would visit the Methodist Rehabilitation Center six times over 3 to 5 weeks. Each visit involves taking a study medication or placebo, followed by 30 minutes of spinal stimulation, with assessments before, during, and after.
- Compensation
- Not stated in the trial record.
- Follow-up
- Spinal reflexes and clinical assessments are evaluated before, during, and after each intervention, with the post-intervention measurement at 100 minutes.
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Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Matthias J Krenn, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Mississippi Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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 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.
- 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.