RECRUITING

Incomplete Cervical SCI Without Instability

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

A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.

Official Title

IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis

Quick Facts

Study Start:2023-12-11
Study Completion:2027-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05653206

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. * Age 18-80 years, inclusive
  2. * Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 48 hours post injury
  3. * Cervical neurological level of injury (C2-C8)
  4. * MRI, using any imaging protocols (conventional, multiparametric, or quantitative), taken according to standard of care
  5. * Presence of spinal cord compression on the MRI
  6. * Absence of biomechanical instability to the extent that would mandate stabilization surgery by the treating surgeon
  7. * Ability to provide informed consent according to the IRB/EC defined and approved procedures
  1. * Nontraumatic SCI
  2. * Concomitant traumatic brain injury or polytrauma that could preclude accurate or reliable assessments of the outcome assessments
  3. * Uncontrolled severe systemic diseases, preexisting neurological, musculoskeletal, or general medical conditions which could preclude accurate assessments or FUs
  4. * Individuals unable to undergo MRI

Contacts and Locations

Study Contact

Alix Frischknecht
CONTACT
+41 79 606 41 48
alix.frischknecht@aofoundation.org
Joelle Kägi
CONTACT
+41 79 549 32 83
joelle.kaegi@aofoundation.org

Principal Investigator

Jefferson Wilson
PRINCIPAL_INVESTIGATOR
Unity Health Toronto

Study Locations (Sites)

San Francisco General Hospital
San Francisco, California, 94143
United States
UMD STC Neurosurgery Clinic
Baltimore, Maryland, 21201
United States
Medical college of Winsconsine, Neurosurgery
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: AO Foundation, AO Spine

  • Jefferson Wilson, PRINCIPAL_INVESTIGATOR, Unity Health Toronto

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 Date2023-12-11
Study Completion Date2027-08-01

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2027-08-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cervical Spinal Cord Injury