Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Phase 1RecruitingNCT07050173

Pravat Mandal30 enrolled

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Repetitive Head Impacts

Interventions

Gamma-glutamylcysteine (GGC)DRUG

400mg tablet orally (two times) per day.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 ≥ 1.5 ULN; ALT ≥1.5 ULN) 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.

Locations (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.

(MRS) is a non-invasive imaging technique, to detect various neurochemical (e.g. glutathione) using MEGA-PRESS sequence from 1H MR spectroscopy.

Time frame: 12 months

Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation.

Time frame: 12 months

Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation.

Time frame: 12 months

Secondary Outcomes

Correlation between glutathione and iron levels in the brain and blood with dysbiotic features of the gut microbiome in people with RHI.

Brain imaging, blood and stool samples will be collected to determine the correlation between glutathione and iron levels in the brain and blood with dysbiotic features of the gut microbiome in people with RHI.

Time frame: 12 months

Changes from baseline in the cognitive functions (immediate memory, visuospatial memory, language etc) using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) in people with RHI .

Interpretation: Higher scores \> 70 indicate greater cognitive function (PMID =36648917)

Time frame: 12 months

Changes in brain iron levels (ppb) in people with RHI using susceptibility mapping between pre and post supplementation.

Time frame: 12 months

Changes from baseline in the cognitive functions ( executive functions like attention, speed, and mental flexibility ) using Trail Making Test (TMT) A&B in people with RHI.

Central Contacts

Pravat K MANDAL, PHD

CONTACT

4126999561 mandalpk@pitt.edu

Data from ClinicalTrials.gov

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