Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Last updated: June 28, 2024
Sponsor: University of Mississippi Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Spinal Cord Injuries

Spinal Cord Disorders

Treatment

Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen

Transcutaneous spinal stimulation at 100 Hz

Sham transcutaneous spinal stimulation

Clinical Study ID

NCT06274021
UMMC-IRB-2023-125
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

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 ofSpasticity Severity [range from 0 to 10])

  • If needed, agreement to reduce antispastic medication

Exclusion

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 kneejoints

  • Botulinum toxin injections in lower extremities in the previous 3 months beforeenrollment

  • 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 30days preceding and during the present study

  • Other medical risks/contraindications as determined by the study physicians

Study Design

Total Participants: 16
Treatment Group(s): 5
Primary Treatment: Transcutaneous spinal stimulation at 50 Hz and single dose of baclofen
Phase: 1
Study Start date:
March 01, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The primary questions to be addressed are whether the intervention reduces muscle stiffness and spasms and alters spinal reflexes:

  • Using a 100-Hz (a measure of frequency) transcutaneous spinal stimulation is better than using a 50-Hz.

  • Transcutaneous spinal stimulation at 50 Hz differs from a single dose of baclofen.

  • Transcutaneous spinal stimulation at 50 Hz differs from a single dose of tizanidine.

  • Combining the 50 Hz stimulation with either baclofen or tizanidine decreases spasticity more than just taking the medicine alone.

Participants will visit the Methodist Rehabilitation Center in Jackson, Mississippi, six times over a period of 3 to 5 weeks. During the first visit, the overall health and motor and sensory functions will be assessed following a spinal cord injury. For the next five visits, participants will take a study medication (tizanidine, baclofen, or a placebo). After an hour, they will receive a continuous 30-minute transcutaneous spinal stimulation at either 50 Hz, 100 Hz, or sham. The spinal reflexes and clinical assessments will be evaluated before, during, and after each intervention.

Connect with a study center

  • Methodist Rehabilitation Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

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