Using electrical stimulation to reduce muscle stiffness after spinal cord injury
Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation
This study tests if electrical stimulation can help reduce muscle stiffness and spasms in people with spinal cord injuries compared to standard muscle relaxants.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Mississippi Medical Center Academic / other |
| Locations | 2 sites (Jackson, Mississippi and 1 other locations) |
| Trial ID | NCT06274021 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous spinal stimulation on muscle stiffness and spasms in individuals with spinal cord injuries. Participants will receive different levels of electrical stimulation and will be compared to standard muscle relaxants like baclofen and tizanidine. The study aims to determine the effectiveness of this non-surgical intervention in alleviating symptoms associated with spinal cord injuries. Participants will undergo assessments over six visits at the Methodist Rehabilitation Center in Jackson, Mississippi, to evaluate their response to the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of spinal cord injury and spasticity in the lower limbs.
Not a fit: Patients with neurological injuries below T11 or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for reducing muscle stiffness and spasms in patients with spinal cord injuries.
How similar studies have performed: While this approach is novel, other studies have explored neuromodulation techniques, indicating potential for success in similar interventions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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, Ph.D. — University of Mississippi Medical Center
- Study coordinator: Matthias J Krenn, Ph.D.
- 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.