RECRUITING

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

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

This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.

Official Title

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT): a Phase 2 Randomized, Feasibility Trial

Quick Facts

Study Start:2022-12-16
Study Completion:2026-09-20
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05337618

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 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. persistent bilateral non-reactive pupils or other evidence of non-survivable injury,
  2. 2. decompressive craniectomy to treat refractory ICP subsequent to diffuse injury, (3) co-enrollment in another therapeutic TBI trial, and

Contacts and Locations

Study Contact

Jed A Hartings, PhD
CONTACT
513-295-2370
jed.hartings@uc.edu
Karmen Herzig
CONTACT
513-558-0440
herzigkm@ucmail.uc.edu

Study Locations (Sites)

University of Cincinnati
Cincinnati, Ohio, 45267
United States

Collaborators and Investigators

Sponsor: University of Cincinnati

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 Date2022-12-16
Study Completion Date2026-09-20

Study Record Updates

Study Start Date2022-12-16
Study Completion Date2026-09-20

Terms related to this study

Additional Relevant MeSH Terms

  • Traumatic Brain Injury