RECRUITING

Feasibility of Early Gabapentin as an Intervention for Neurorecovery

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 objective of the proposed study is to conduct the first ever prospective, dose-exploration trial to test the feasibility of early administration of gabapentin as an intervention for neurorecovery. This research project falls under the Intervention Development stage of research as the primary goal is to assess the feasibility of conducting a well-designed intervention efficacy study in the future.

Official Title

Feasibility of Early Gabapentin as an Intervention for Neurorecovery

Quick Facts

Study Start:2022-03-14
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05302999

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Traumatic SCI;
  2. 2. All levels of SCI;
  3. 3. All severities of SCI, AIS A-D;
  4. 4. Age 18 years and older.
  5. 5. Agree to participate and start study drug within 120 hours' post-injury.
  6. 6. Adequate cognition and communication to provide informed consent
  1. 1. Presence of moderate/severe traumatic brain injury (TBI) as defined by Glasgow Coma Score (GCS) \< 13 at 120 hours' post-injury.
  2. 2. Documented use of gabapentinoids at the time of injury.

Contacts and Locations

Study Contact

Megan Hammond, M.Ed
CONTACT
216-957-3562
mhammond1@metrohealth.org

Principal Investigator

Dr. Kimberly Anderson, PhD
PRINCIPAL_INVESTIGATOR
Metrohealth Medical Center-Case Western Reserve University School of Medicine

Study Locations (Sites)

MetroHealth Medical Center
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • Dr. Kimberly Anderson, PhD, PRINCIPAL_INVESTIGATOR, Metrohealth Medical Center-Case Western Reserve 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 Date2022-03-14
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2022-03-14
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Gabapentin
  • Neurorecovery
  • Feasibility

Additional Relevant MeSH Terms

  • Spinal Cord Injuries