UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Location contact
Nazia Pillar, Ms
CONTACT
Pravat K Mandal, PhD
CONTACT
Pravat K Mandal, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07050173
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.
Interested in participating?
Request Info30 year–70 year
All sexes
Interventional
Phase 1
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Nazia Pillar, Ms
CONTACT
Pravat K Mandal, PhD
CONTACT
Pravat K Mandal, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
400mg tablet orally (two times) per day.
Other names: GGC
Time frame: 12 months
(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
Time frame: 12 months
Time frame: 12 months
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
Interpretation: Higher scores > 70 indicate greater cognitive function (PMID =36648917)
Time frame: 12 months
Time frame: 12 months
Scoring Method: The average scores are as follows:
Time frame: 12 months
Interpretation: Higher score (> 7) (PMID=21122190) indicates greater executive functions which includes cognitive abilities essential for tasks such as planning, problem-solving, and decision-making.
Time frame: 12 months
Interpretation of the results: Higher scores (>45 above 315191110 indicate better cognitive and memory function.
Time frame: 12 months
Scoring Method: Each item is scored on a 0-4 scale, with the total score indicating the severity of distress.
Interpretation: Higher total scores indicate greater severity of psychological distress.
Time frame: 12 months
Scoring Method:
Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty.
Contact information is provided by the study sponsor or research team.
Pravat Mandal
Other
Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological Testing
Acronym: RHIGSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07010887
Repetitive Head Impacts
Bloomington, Indiana, United States
View Trial DetailsNCT07688746
Brain Diseases, Brain Injuries
San Francisco, California, United States
View Trial DetailsNCT07215195
Acquired Brain Injury (Including Stroke), Brain Diseases
Oxford, United Kingdom
View Trial DetailsNCT07448103
Acquired Brain Injury, Brain Diseases
Madrid, Spain
View Trial Details