Using Real-Time Functional Brain Imaging to Enhance Recovery From TBI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Neuropsychological assessments
研究概览
简要总结
In this randomized, controlled clinical trial, we will evaluate the effects of (1) a brain-training program that uses real-time neurofeedback in functional magnetic resonance imaging (fMRI) to allow people to learn how to gain voluntary control over activity in targeted brain regions and/or (2) 8 weeks of computer-based cognitive training using a software program (Cognitive Remediation for Brain Injury (CRBI)) versus control training tasks on cognitive learning and symptoms. In addition, the investigators will measure brain function (active and resting functional magnetic resonance imaging) and structure (high resolution magnetic resonance imaging) before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild TBI: PTA/confusion≤1 hour immediately after injury; or LOC <30 min [69] confirmed by the Ohio confirmed by the Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF).
- •Age 18-45 years
- •Right handed [70].
- •Minimum of 4 months and within 36 months post-injury
- •Can participate in fMRI and outcome assessment
- •Adequate visual, auditory, sensory-motor function for training program.
- •Fluent in English
- •Persistent cognitive dysfunction confirmed by an objective measure
排除标准
- •History of hypoxic event
- •Pre-existing significant neurological (e.g. MS) or psychiatric (e.g. schizophrenia, bi-polar) disorders.
- •Current illicit drug use or ETOH abuse
- •Contraindications to MRI (metal, pregnant, pacemaker, claustrophobia, etc.).
- •Unwilling or unable (e.g. language barrier) to participate
- •Hospitalization during study
- •Current Med Board for discharge, Litigation/ + malingering test [71]
- •Use of medications to enhance cognitive function (e.g. Ritalin)
- •Initial Glascow Coma Score <13 or penetrating head injury
- •Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; 111). Subjects with a score of 4 or 5 (as recommended by the FDA for treatment trials) will be excluded and referred for appropriate treatment.
- •Subjects should not be enrolled in a concurrent TBI clinical trial.
结局指标
主要结局
Neuropsychological assessments
时间窗: 8 weeks
A composite score based on four primary domains (learning, memory, working memory and executive function).
次要结局
- Participant-reported outcomes(8 weeks)
- Working/School Status(8 weeks)
- Exercise Based Assessments(4 and 8 weeks)
- Functional Assessments(8 weeks)