Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- California Verbal Learning Test
研究概览
简要总结
The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).
详细描述
The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •I am between the ages of 18 and 75 years old.
- •I have a spinal cord injury with the level of injury between C1-T
- •I am non-ambulatory (I use a wheelchair as my primary means of getting around).
- •I have an AIS grade of A, B or C as determined by study staff examination.
- •My injury occurred at least 1 year ago.
- •My primary language is English.
排除标准
- •I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
- •I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
- •I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
- •I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
- •My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
- •I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.
结局指标
主要结局
California Verbal Learning Test
时间窗: Assessments will look at change over 6 weeks of treatment and 3 months after completion
California Verbal Learning TestPerformance on a memory test using the
次要结局
- SCI Quality of Life Scale(Assessments will look at change over 6 weeks of treatment and 3 months after completion)
研究者
Nancy Chiaravalloti
Director NNL & TBI
Kessler Foundation