Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Mississippi Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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])

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous spinal stimulation at 100 Hz
  • Transcutaneous spinal stimulation at 50 Hz
  • Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen
  • Transcutaneous spinal stimulation at 50 Hz and single dose of tizanidine
  • Sham transcutaneous spinal stimulation

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Mississippi Medical Center

Lead sponsor

Methodist Rehabilitation Center

Collaborator

The Craig H. Neilsen Foundation

Collaborator