Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological Testing
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.
研究概览
简要总结
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:
- Change in GSH in brain and blood levels through GGC supplementation.
- Change in the cognitive function in RHI patients due to GGC supplementation.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Subjects with active psychosis or delirium;
- •Subjects with chronic kidney (creatinine > 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥1.5 ULN) within 30 days prior to enrollment;
- •Subjects on antioxidant therapy (gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl;
- •Repeated head injury patients with neurosurgical intervention and;
- •Subjects with repeated head injury within the last 90 days.
研究组 & 干预措施
Gamma - Glutamylcystiene
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.
干预措施: Gamma-glutamylcysteine (GGC) (Drug)
结局指标
主要结局
Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.
时间窗: 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.
时间窗: 12 months
Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation.
时间窗: 12 months
次要结局
- 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.(12 months)
- Correlation between glutathione and iron levels in the brain and blood with dysbiotic features of the gut microbiome in people with RHI.(12 months)
- 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 .(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(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)(12 months)
- Changes from baseline in the cognitive functions and emotional wellbeing using Brief Symptom Inventory (BSI-18) (self-report) in people RHI .(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.(12 months)
研究者
Pravat Mandal
Research Assistant Professor
University of Pittsburgh