RECRUITING

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Conditions

Repetitive Head Impacts Brain injury Glutathione MR spectroscopy Non- invasive GGC RHI TES Brain Blood

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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 clinical trial is to test whether the gamma - glutamylcystiene (GGC) oral supplement can reach the brain and subsequently increase antioxidant glutathione (GSH) level in people with repetitive head impact (RHI). This will reduce the oxidative stress related injury in people with RHI.This unique study's main objective is to test the: 1. Change in GSH in brain and blood levels through GGC supplementation. 2. Change in the cognitive function in RHI patients due to GGC supplementation.

Official Title

Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological Testing

Quick Facts

Study Start:2025-10-01

Study Completion:2027-12-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07050173

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:30 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Retired NFL player, retired Navy SEAL/army personnel with combat experience exposed to repetitive head impact; * Memory and behavioral complaint per self- or informant-report; * Age (30 to 70 years of age) years; * Able to read and write in English and to give consent to participate in the study.	* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body. * Subjects with claustrophobia. * Subject with mild cognitive impairment \[TICS score of 29 or lower OR \>=1.0 standard deviations below age-expectation on at least two cognitive members within the same cognitive domain (e.g. memory, attention, etc.) on the baseline neuropsychological testing; * Subjects with a history of cancer; * Subjects with active psychosis or delirium; * Subjects with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST/ALT \> 2 upper limit of normal) within 30 days prior to enrollment; * Subjects on antioxidant therapy (gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl; * Repeated head injury patients with neurosurgical intervention and; * Subjects with repeated head injury within the last 90 days.

Inclusion Criteria

Exclusion Criteria

* Retired NFL player, retired Navy SEAL/army personnel with combat experience exposed to repetitive head impact;
* Memory and behavioral complaint per self- or informant-report;
* Age (30 to 70 years of age) years;
* Able to read and write in English and to give consent to participate in the study.

* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
* Subjects with claustrophobia.
* Subject with mild cognitive impairment \[TICS score of 29 or lower OR \>=1.0 standard deviations below age-expectation on at least two cognitive members within the same cognitive domain (e.g. memory, attention, etc.) on the baseline neuropsychological testing;
* Subjects with a history of cancer;
* Subjects with active psychosis or delirium;
* Subjects with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST/ALT \> 2 upper limit of normal) within 30 days prior to enrollment;
* Subjects on antioxidant therapy (gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl;
* Repeated head injury patients with neurosurgical intervention and;
* Subjects with repeated head injury within the last 90 days.

Contacts and Locations

Study Contact

Pravat K MANDAL, PHD

CONTACT

4126999561

mandalpk@pitt.edu

Principal Investigator

Pravat K Mandal, PhD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Pravat Mandal

Pravat K Mandal, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

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 Date2025-10-01

Study Completion Date2027-12-27

Study Record Updates

Study Start Date2025-10-01

Study Completion Date2027-12-27

Terms related to this study

Keywords Provided by Researchers

Brain injury
Glutathione
MR spectroscopy
Non- invasive
GGC
RHI
TES
Brain
Blood

Additional Relevant MeSH Terms

Repetitive Head Impacts