RECRUITING

Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)

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Conditions

Spinal Cord InjuriesPeripheral Nerve Injuries

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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

The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.

Official Title

Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)

Quick Facts

Study Start:2024-11-01
Study Completion:2029-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06672458

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 to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Neurological Injury:
  2. 1. Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade
  3. * Group 1 (Acute SCI): Deemed medically stable by medical practitioner, less than 6 months post-injury.
  4. * Group 2 (Chronic SCI): More than 6 months post-injury.
  5. 2. Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery
  6. * Group 3 (Acute Pre- or Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon within 6 months pre- or post-UE nerve transfer surgery.
  7. * Group 4 (Chronic Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon 6 months or more post-UE nerve transfer surgery.
  8. 3. Has detectable residual connection in upper-limb muscles in at least one of the neurologically affected sides confirmed by a visible contraction when functional electrical stimulation (FES) is applied in at least one upper extremity muscle at baseline.
  9. 4. Has detectable motor function in at least 1 upper extremity muscle on 1 neurologically affected side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) at the baseline assessment. 5. (Aim 2 only) Able to commit to intervention and assessment sessions over a maximum duration of 4 months.
  10. 1. Traumatic brain injury, stroke, multiple sclerosis, or other disorders that could affect neuromotor function.
  11. 2. Severe spasticity that could prevent the study protocol as determined by the investigator.
  12. 3. Major executive dysfunction, dementia, depression, neurocognitive impairments, or other major medical co-morbidities.
  13. 4. Has contraindications for transcutaneous stimulation using FES such as breakdown of skin in the area that will come into contact with electrodes, thrombosis, or skin disease
  14. 5. Poorly managed autonomic dysreflexia that could be triggered by FES.
  15. 6. Unhealed upper extremity fracture, contracture, or pressure sore.
  16. 7. Implanted neurostimulator (e.g., deep brain stimulation (DBS), epidural/subdural, vagal nerve stimulation (VNS))
  17. 8. Cardiac pacemaker or intracardiac lines.
  18. 9. Individuals who require therapy or other care that could interfere with participation in the study.
  19. 10. Individuals on investigational drugs or any other intervention known to have a potential impact on neuromotor function.
  20. 11. Individuals with substance disorders, including alcoholism and drug abuse.
  21. 12. Individuals who are pregnant, breastfeeding, or the desire to become pregnant during the study.
  22. 13. In the opinion of the investigators, the study is not safe or appropriate for the participant.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cristina Thurston, DPT
CONTACT
(305) 243-9301
cst58@med.miami.edu
Deena Cilien, DPT
CONTACT
(305) 243-9301
dcilien@med.miami.edu

Principal Investigator

Matija Milosevic, PhD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: University of Miami

  • Matija Milosevic, PhD, PRINCIPAL_INVESTIGATOR, University of Miami

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 Date2024-11-01
Study Completion Date2029-01-31

Study Record Updates

Study Start Date2024-11-01
Study Completion Date2029-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Peripheral Nerve Injuries