Task Practice and Spinal Cord Stimulation

Last updated: September 14, 2024
Sponsor: University of Miami
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)

Clinical Study ID

NCT06494020
20230228
  • Ages 22-70
  • All Genders

Study Summary

The goal of this study is to understand the effects of combined task practice with transcutaneous cervical spinal cord stimulation. The study will explore the effect of higher stimulation frequencies on spasticity. Transcutaneous stimulation has been shown to improve motor function in some individuals with chronic spinal cord injury. The study intends to explore scientifically the association between higher stimulation frequencies and spasticity/hypertonicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 22-70 years of age

  • Non-progressive cervical spinal cord injury

  • Minimum 12 months year post-injury.

  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B,C, or D.

  • Able to take part in upper extremity therapy procedures.

  • GRASSP-Prehension score ≥10.

  • MAS Score ≥3 but <6 in at least one arm.

  • Can commit to the time required for the study.

  • Stable medication profile for at least 4 weeks prior to enrollment.

  • Able to reduce Baclofen dose to 30 mg or less daily.

  • Capable of providing informed consent.

Exclusion

Exclusion Criteria:

  • Has any unstable or significant medical condition that is likely to interfere withstudy procedures like severe neuropathic pain, depression, mood disorders, or othercognitive disorders.

  • Has uncontrolled cardiopulmonary disease or cardiac symptoms.

  • Requires ventilator support.

  • Has been diagnosed with autonomic dysreflexia that is severe, unstable, anduncontrolled.

  • Has an autoimmune etiology of spinal cord dysfunction/injury

  • Previously diagnosed as having transverse myelitis

  • History of additional neurologic diseases such as stroke, multiple sclerosis,traumatic brain injury, epilepsy or history of seizures.

  • Peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.)

  • Uncontrolled spasms, which have been unstable over the past three months prior toenrollment and are not expected to change.

  • Received Botulinum toxin injections in their upper extremity, neck, or hand withinsix months prior to enrollment.

  • Has painful musculoskeletal dysfunction, unhealed fracture, contracture, pressuresore, or urinary tract infection at the time of enrollment.

  • Breakdown in skin area that will come into contact with electrodes.

  • Presence of syringomyelia as determined by an MRI.

  • Currently undergoing treatment for cancer or has been in remission for less than 2years.

  • Received stem cell treatment within the past two years prior to enrollment.

  • Has any active implanted medical device.

  • Concurrent participation in another drug or device trial that may interfere withthis study.

  • In the opinion of the investigators, the study is not safe or appropriate for theparticipant.

  • Persons who are unable to consent, pregnant women, and prisoners.

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Task Practice combined with Transcutaneous Spinal Cord Stimulation( TcSCS)
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
October 01, 2027

Connect with a study center

  • University of Miami - Christine E. Lynn Rehabilitation Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • University of Miami, Miller School of Medicine, The Miami Project To Cure Paralysis

    Miami, Florida 33136
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.