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Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

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.

Conditions

Repetitive Head Impacts
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Related Conditions:

Repetitive Head Impacts

Study Overview

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Study Details

Study overview

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.

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

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Condition
Repetitive Head Impacts
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, United States, 15213

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

30 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pravat Mandal,

Pravat K Mandal, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2027-12-27