Electrical stimulation for managing spasticity in spinal cord injury patients
Transcutaneous Spinal Stimulation for Reducing Lower Limb Spasticity in Chronic Spinal Cord Injury: a Cross-over Study of Immediate Effects and Outcomes of Home-based Therapy Trials
NA · University of Mississippi Medical Center · NCT05457205
This study is testing whether a new electrical stimulation treatment can help adults with spinal cord injuries reduce muscle stiffness and improve their mobility and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Mississippi Medical Center (other) |
| Locations | 2 sites (Jackson, Mississippi and 1 other locations) |
| Trial ID | NCT05457205 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of transcutaneous spinal stimulation (TSS) to manage lower limb spasticity in individuals with spinal cord injuries (SCI). TSS is a non-pharmacological approach that aims to modify spinal motor output through electrical neuromodulation, potentially alleviating symptoms of spasticity such as increased muscle tone and involuntary contractions. Participants will be individuals aged 18 and older with a history of SCI and at least mild spasticity. The study will assess the effectiveness of TSS in improving mobility and quality of life for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of spinal cord injury and at least mild spasticity in their lower limbs.
Not a fit: Patients with neurological levels of SCI below T11 or those with implanted active devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce spasticity and improve mobility and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies using similar electrical stimulation techniques have shown promising results in managing spasticity, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * History of SCI (ASIA Impairment Scale grades A-D) * Time since injury longer than 6 months * The presence of at least mild spasticity (\>3) in the lower limbs by self-report of the Numerical Rating Scale (from 0 to 10) of spasticity severity * Signed consent form Exclusion Criteria: * Neurological level of SCI below T11 * Suspected progression of SCI (e.g., syringomyelia) * Ventilatory-dependent * Implanted active devices (e.g., intrathecal baclofen pumps) * Passive implants (plates, screws) between T10 and L3 vertebras * Skin conditions precluding placement of electrodes * Ongoing infections * Pregnancy * Difficulty following instructions * No access to a caregiver/family member to help with electrode placement at home * Other medical risks/contraindications as determined by the study physicians
Where this trial is running
Jackson, Mississippi and 1 other locations
- Methodist Rehabilitation Center — Jackson, Mississippi, United States (RECRUITING)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (RECRUITING)
Study contacts
- Principal investigator: Matthias J Krenn, PhD — University of Mississippi Medical Center
- Study coordinator: Matthias J Krenn, PhD
- Email: mkrenn@umc.edu
- Phone: 601-364-3413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Spasticity, Muscle, Transcutaneous Spinal Cord Stimulation, Neuromodulation, Electrical Stimulation, Spasticity, Lower Extremities