Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury

This study is looking at a non-drug treatment called transcutaneous spinal stimulation (TSS) for lower limb spasticity (muscle stiffness and spasms) in people with spinal cord injuries. Spasticity can make daily activities difficult and cause pain. TSS uses electrical neuromodulation, which involves placing electrodes on your back and abdomen to deliver electrical signals. The researchers want to see if TSS can reduce spasticity by measuring changes in your reflexes. You might be able to join if you are 18 or older, have had a spinal cord injury for more than 6 months, and experience at least mild spasticity in your legs. The study plans to enroll 12 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 12 participants.
What's involved
The study will involve an intervention session lasting 15-30 minutes, during which reflex measurements will be taken.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken before and after an intervention session (30 minutes), and before and during an intervention session (15 minutes).

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NCT05457205

Transcutaneous Spinal Stimulation for Lower Limb Spasticity in Spinal Cord Injury

UNKNOWN
NAAges 18+InterventionalTreatment
University of Mississippi Medical Center
~12 participants
Updated 2024-04-12 on ClinicalTrials.gov
What's tested:Electrical neuromodulation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in posterior root reflex amplitude
Measured over Before and after an intervention session (30 minutes)
+5 more outcomes measured
Spinal Cord Injuries
Spasticity, Muscle
2 sites across 1 states
Mississippi2
  • Matthias J Krenn, PhD · PRINCIPAL_INVESTIGATOR · University of Mississippi Medical Center

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Eligibility criteria

Inclusion

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

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
  • Change in posterior root reflex amplitudeBefore and after an intervention session (30 minutes)

    The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.

  • Change in posterior root reflex amplitude (during intervention)Before and during an intervention session (15 minutes)

    The amplitudes of the posterior root reflexes will be calculated and normalized to the maximum response amplitude from the recruitment curve for each muscle separately. The respective values will be averaged over all muscles and used as an outcome measure.

  • Change in flexion withdrawal reflex root-mean-squareBefore and after an intervention session (30 minutes)

    The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.

  • Change in flexion withdrawal reflex root-mean-square (during intervention)Before and during an intervention session (15 minutes)

    The cumulative root-mean-square values of the reflex amplitude in a window from 50 to 200 ms after the stimulation pulse over all recorded muscles.

  • Change in pendulum test indexBefore and after an intervention session (30 minutes)

    The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.

  • Change in pendulum test index (during intervention)Before and during an intervention session (15 minutes)

    The pendulum test provides the spasticity index which is calculated based on the knee angle of the initial horizontal leg position of the pendulum test, the angle at which the leg reversed for the first time from flexion to extension, and the final knee resting angle.