RECRUITING

Neuromodulation to Reduce Muscle Stiffness Following Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Shared and Distinct Antispastic Effects of Electrical and Pharmacological Neuromodulation

Quick Facts

Study Start:2024-03-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06274021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * History of spinal cord injury
  3. * Time since diagnosis longer than six months
  4. * Presence of spasticity in the lower limbs (≥ 3 on the Numerical Rating Scale of Spasticity Severity \[range from 0 to 10\])
  5. * If needed, agreement to reduce antispastic medication
  1. * Neurological level of spinal cord injury below T11
  2. * Ventilatory-dependent
  3. * Change in neurological status over the past 2 months
  4. * Rigidity, contraction, or passive range of motion of less than 40 deg in both knee joints
  5. * Botulinum toxin injections in lower extremities in the previous 3 months before enrollment
  6. * Systolic blood pressure at rest lower than 90 mm Hg
  7. * Implanted active devices (e.g., intrathecal baclofen pumps)
  8. * Passive implants (plates, screws) between T11 and L2 vertebras
  9. * Skin conditions precluding placement of electrodes
  10. * Pressure ulcers stage 2 or higher on the gluteal area or lower extremities
  11. * Receiving antibiotics for infections
  12. * Pregnancy
  13. * Difficulty following instructions
  14. * Participation in another study with investigational drugs or devices within the 30 days preceding and during the present study
  15. * Other medical risks/contraindications as determined by the study physicians

Contacts and Locations

Study Contact

Matthias J Krenn, Ph.D.
CONTACT
601-364-3413
mkrenn@umc.edu
Dobrivoje S Stokic, M.D., D.Sc.
CONTACT
601-364-3314
dstokic@mmrcrehab.org

Principal Investigator

Matthias J Krenn, Ph.D.
PRINCIPAL_INVESTIGATOR
University of Mississippi Medical Center

Study Locations (Sites)

Methodist Rehabilitation Center
Jackson, Mississippi, 39216
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States

Collaborators and Investigators

Sponsor: University of Mississippi Medical Center

  • Matthias J Krenn, Ph.D., PRINCIPAL_INVESTIGATOR, University of Mississippi Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Neuromodulation
  • Electrical Stimulation
  • Spinal Cord Stimulation
  • Spasticity
  • Transcutaneous Spinal Stimulation
  • Lower extremity
  • Transcutaneous spinal cord stimulation
  • Paralysis
  • Spinal reflex

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Spinal Cord Injury
  • Spinal Cord Injury Cervical
  • Spinal Cord Injury Thoracic