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

NCT07050173 Phase 1 RECRUITING

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.

Details

Lead sponsor	Pravat Mandal
Phase	Phase 1
Status	RECRUITING
Enrolment	30
Start date	2026-04
Completion	2027-12-27

Conditions

• Repetitive Head Impacts

Interventions

• Gamma-glutamylcysteine (GGC)

Primary outcomes

• Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation. — 12 months
  (MRS) is a non-invasive imaging technique, to detect various neurochemical (e.g. glutathione) using MEGA-PRESS sequence from 1H MR spectroscopy.
• Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation. — 12 months
• Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation. — 12 months

Countries

United States