Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation
ConditionRepetitive Head Impacts
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30-70
SponsorPravat Mandal
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Gamma-glutamylcysteine (GGC)
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Pravat Mandal
Lead sponsor
University of Pittsburgh
Sponsor institution
Chuck Noll Foundation
Collaborator
Source ClinicalTrials.gov