Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Gamma-glutamylcysteine (GGC)

    Drug

    400mg tablet orally (two times) per day.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Gamma - GlutamylcystieneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Time frame
12 months
3

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

Time frame
12 months

Secondary outcomes

1

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
2

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
3

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

Time frame
12 months
4

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.

Scoring Method: The average scores are as follows: * Trail A - 29 seconds * Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pravat Mandal

Lead sponsor

University of Pittsburgh

Sponsor institution

Chuck Noll Foundation

Collaborator

Source ClinicalTrials.gov
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