NCT00714571已完成1 期
Behavioral and Neuroimaging Changes After Cognitive Rehab in TBI and MCI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Memory Test Accuracy on Trained Stimuli
研究概览
简要总结
Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of various forms of dementia, such as Alzheimer's disease and its common precursor mild cognitive impairment (MCI). This project intends to assess the efficacy of cognitive rehabilitation in these patient populations. We will also use neuroimaging (functional magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following cognitive rehabilitation.
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
- Single
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General inclusion criteria (all patients):
- •A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;
- •All medications stable for approximately 3 months;
- •No history of severe mental illness;
- •No current untreated alcohol or substance abuse/dependence;
- •English as native and preferred language;
- •MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.
- •MCI Inclusion Criteria:
- •Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004). Additionally, other potential causes of cognitive deficit ruled out by the referring physician;
- •55 years of age or older.
- •TBI Inclusion criteria:
- •History of a mild to moderate TBI;
- •No history of other neurological disease or injury;
- •A minimum of 6 months and maximum of 5 years post-onset of TBI;
- •18 - 45 years old.
排除标准
- •History of neurological disease or injury (other than TBI)
- •History of severe mental illness
- •Current untreated alcohol or substance abuse
- •Other conditions may exclude; please discuss with contact
结局指标
主要结局
Memory Test Accuracy on Trained Stimuli
时间窗: Pre-training, post-training, 1 month
Accuracy (Percent correct) for trained stimuli. Stage 1: Object location association test Stage 2: Face name association test
次要结局
未报告次要终点
研究者
研究点 (2)
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