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NCT07050173 | RECRUITING | Repetitive Head Impacts

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation
Sponsor:

Pravat mandal

Information provided by (Responsible Party):

Pravat mandal

Brief Summary:

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.

Condition or disease

Repetitive Head Impacts

Intervention/treatment

Gamma-glutamylcysteine (GGC)

Phase

PHASE1

Detailed Description:

This study is designed to evaluate the effects of GGC supplementation in patients with a history of repetitive head impacts (RHI) who are at risk for developing Traumatic Encephalopathy Syndrome (TES). The trial will include specific individuals who satisfy the eligibility criteria.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological Testing
Actual Study Start Date : 2025-10-01
Estimated Primary Completion Date : 2027-11-01
Estimated Study Completion Date : 2027-12-27

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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.
Exclusion Criteria
  • * 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.
Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Location Details

NCT07050173

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213