RECRUITING

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

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

In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.

Official Title

Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia

Quick Facts

Study Start:2023-01-25
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05157282

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female Veterans between 18-70 years
  2. * Chronic SCI (1 year of injury)
  3. * Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI \[preliminary data (Benavides et al., 2020) and analysis of MRIs in \~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments
  4. * Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020)
  5. * Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020)
  6. * Able to produce a visible power grip with one hand
  7. * Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP
  8. * This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests
  9. * Males and females (18-70 years)
  10. * Right-handed
  11. * Able to complete grasping
  1. * Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
  2. * Any debilitating disease prior to the SCI that caused exercise intolerance
  3. * Premorbid, ongoing major depression or psychosis, altered cognitive status
  4. * History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke
  5. * Pacemaker
  6. * Metal plate in skull
  7. * History of seizures
  8. * Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
  9. * Pregnant females
  10. * Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk

Contacts and Locations

Study Contact

Monica A Perez, PhD
CONTACT
(312) 238-2886
mperez04@sralab.org

Principal Investigator

Monica A Perez, PhD
PRINCIPAL_INVESTIGATOR
Edward Hines Jr. VA Hospital, Hines, IL

Study Locations (Sites)

Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Monica A Perez, PhD, PRINCIPAL_INVESTIGATOR, Edward Hines Jr. VA Hospital, Hines, IL

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 Date2023-01-25
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-01-25
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Motor Function
  • Reaching
  • Grasping
  • Hand Movement

Additional Relevant MeSH Terms

  • Spinal Cord Injury