Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury
Spinal Cord Injuries, Spasticity, Muscle
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Transcutaneous Spinal Cord Stimulation, Neuromodulation, Electrical Stimulation, Spasticity, Lower Extremities
Eligibility 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
Sites / Locations
- Methodist Rehabilitation CenterRecruiting
- University of Mississippi Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Neuromodulation with 50 Hz and low intensity
Neuromodulation with 50 Hz and high intensity
Neuromodulation with 100 Hz and low intensity
Neuromodulation with 100 Hz and high intensity
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles).
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 50 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles).
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.45 x lowest motor threshold (reflex threshold in leg muscles).
Transcutaneous spinal stimulation for 30 min with a stimulation frequency of 100 Hz and stimulation intensity of 0.90 x lowest motor threshold (reflex threshold in leg muscles).