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| ID | Type | Description | Link |
|---|---|---|---|
| 0025 | Other Identifier | Chuck Noll Foundation |
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| Name | Class |
|---|---|
| Chuck Noll Foundation | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma - Glutamylcystiene | Experimental | Each participant will receive gamma-glutamyl cysteine (GGC) tablet orally 400mg (two times) per day once in the morning and once in the evening for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma-glutamylcysteine (GGC) | Drug | 400mg tablet orally (two times) per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pravat K MANDAL, PHD | Contact | 4126999561 | mandalpk@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pravat K Mandal, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37257017 | Background | Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31. | |
| 26003861 |
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Clinical study report data will be provided after the study data is analyzed and published. A comprehensive report will be sent to the IRB. The respective agency will be reported accordingly. Requests for the release of data must be submitted in writing to the PI, clearly stating the purpose of the request, the specific data needed, and the intended use. The PI, in collaboration with the research team, will review each request to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements.
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| C017341 | gamma-glutamylcysteine |
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| 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) | 12 months |
| Changes in brain iron levels (ppb) in people with RHI using susceptibility mapping between pre and post supplementation. | 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. | Scoring Method: The average scores are as follows:
| 12 months |
| Changes from baseline in the cognitive functions and emotional well-being using Delis-Kaplan Executive Functioning System (D-KEFS) Color Word Interference test in people with a RHI | 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. | 12 months |
| Changes from baseline in the cognitive functions and emotional well-being using Test of Premorbid Functioning (TOPF ) in people with RHI (PMID=36648917) | Interpretation of the results: Higher scores (>45 above 315191110 indicate better cognitive and memory function. | 12 months |
| Changes from baseline in the cognitive functions and emotional wellbeing using Brief Symptom Inventory (BSI-18) (self-report) in people RHI . | 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. | 12 months |
| Changes from baseline in the cognitive functions and emotional well-being using PROMIS Cognitive Function -Short Form 8a (self-report) tool in people RHI. | Scoring Method: Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty. | 12 months |
| Mandal PK, Saharan S, Tripathi M, Murari G. Brain glutathione levels--a novel biomarker for mild cognitive impairment and Alzheimer's disease. Biol Psychiatry. 2015 Nov 15;78(10):702-10. doi: 10.1016/j.biopsych.2015.04.005. Epub 2015 Apr 14. |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |