RECRUITING

Nerve Transfer to Improve Function in High Level 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

The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. Participants will: * undergo standard of care pre- and post-op testing and study exams * complete pre- and post-questionnaires * undergo standard of care nerve transfer surgeries * follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months * attend therapy at local therapist for up to 2 years postop.

Official Title

Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia

Quick Facts

Study Start:2024-02-05
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06288763

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-80 years of age
  2. * High cervical SCI (motor level C1-C4)
  3. * Motor complete SCI AIS grade A-B
  4. * Plateaued spontaneous recovery for at least 6 months of non-operative therapy
  5. * SCI greater than 6 months and fewer than 60 months since injury
  6. * At least MRC 4/5 donor strength
  7. * Mentally and physically willing and able to comply with evaluations
  1. * Active infection at the operative site or systemic infection
  2. * Any return or ongoing recovery of distal motor function
  3. * Significant joint contractures and/or limitations in passive range of motion in the arm
  4. * Mentally or physically compromised making it impossible to complete study activities
  5. * Immunologically suppressed
  6. * Currently undergoing long-term steroid therapy
  7. * Active malignancy
  8. * Pregnancy

Contacts and Locations

Study Contact

Linda Koester, BS
CONTACT
314-362-7368
koesterl@wustl.edu

Principal Investigator

Wilson Z. Ray, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Stanford University
Stanford, California, 94305
United States
University of Miami
Miami, Florida, 33136
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Washington University in St. Louis
Saint Louis, Missouri, 63110
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Houston Methodist
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Wilson Z. Ray, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2024-02-05
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-02-05
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Injury
  • Cervical spinal cord injury
  • Nerve Transfer Surgery
  • High Cervical Spinal Cord Injury
  • Cervical SCI
  • Tetraplegia
  • Quadriplegia
  • Nerve transfer
  • Spinal Accessory Nerve

Additional Relevant MeSH Terms

  • Cervical Spinal Cord Injury
  • Tetraplegia