RECRUITING

Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

Talk to us

Conditions

Spinal Cord InjuriesCervical Spinal Cord Injury

Quick Navigation

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 goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury

Official Title

Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

Quick Facts

Study Start:2024-08-06
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06225245

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:22 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All participants must provide a signed and dated informed consent form.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. * Male or female aged 22 - 70 years old.
  4. * Must provide documentation from personal primary treating physician that reports stable medical condition.
  5. * Able to passively range bilateral upper extremities within normal mobility parameters including:
  6. * greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension;
  7. * greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees;
  8. * neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;
  9. * ability to passively flex and extend fingers.
  10. * Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
  11. * Six (6) months to 20 years post spinal cord injury.
  12. * Non-progressive spinal cord injury.
  13. * Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.
  14. * Neurological level of injury above T2.
  15. * Eligible for fMRI per safety questionnaire.
  16. * Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.
  1. * Currently involved in another rehabilitation training study.
  2. * Lower motor neuron injury revealed in the upper limbs.
  3. * Stabilization hardware in the cervical spine, preventing implantation of ESS system.
  4. * Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).
  5. * Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).
  6. * Intrathecal baclofen pump therapy for spasticity.
  7. * Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.
  8. * Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
  9. * Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
  10. * Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.
  11. * Body Mass Index (BMI) over 30.
  12. * Pregnancy.

Contacts and Locations

Study Contact

Jenny Dinh
CONTACT
346-238-4654
jtdinh@houstonmethodist.org
Rachel Markley
CONTACT
713-441-3770
rmarkley@houstonmethodist.org

Principal Investigator

Dimitry Sayenko, MD, PhD
PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute

Study Locations (Sites)

The Methodist Hospital Research Institute
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

  • Dimitry Sayenko, MD, PhD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

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 Date2024-08-06
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-08-06
Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Cord Injuries
  • Cervical Spinal Cord Injury