Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: Spinal Cord Injuries, Spinal Cord Injury, Spinal Cord Injury Cervical, Spinal Cord Injury Thoracic
In brief
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.
Key facts
- Study ID
- NCT06274021
- Run by
- University of Mississippi Medical Center
- People needed
- 16
- Starts
- 2024-03-01
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2024-07-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Methodist Rehabilitation Center — Jackson, Mississippi, United States (enrolling)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)
Full record on ClinicalTrials.gov
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