A Randomized Controlled Trial of Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Proportions of simultaneous responders
研究概览
简要总结
The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration.
As secondary objectives, the study aims to:
- demonstrate improvement of specific neuropsychological tests of working memory;
- demonstrate improvement of non-specific tasks involving working memory;
- assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect;
- demonstrate improvement of social integration ability and quality of life;
- demonstrate persistence of effects at 3 months and 6 months after the end of treatment;
- demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.
详细描述
Working memory is an essential cognitive function which allows to store briefly and treat simultaneous informations, but is often altered after a moderate to severe TBI. This alteration results in disabilities and social integration difficulties in the post TBI patients. The study team had developped a standardized and hierarchized rehabilitation program of working memory. Several experiments have shown the efficacy of the program which is now used in routine care by speech-language pathologists and neuropsychologists. However it is necessary to provide a robust demonstration of its efficacy in improving function in daily life.
This randomized multicenter study will be performed in 6 centers in the area of Île-de-France. 54 patients will be randomized 1:1 to receive either specific rehabilitation of working memory or non-specific rehabilitation. A 10-month follow-up is planned for patients of the two arms.
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 (Outcomes Assessor)
盲法说明
Clinical assessment will be performed by an assessor blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 - 65 years;
- •Moderate to severe TBI (Glasgow score between 3 and 12 in the 24 first hours);
- •At least 6 months following TBI;
- •Complaint related to working memory in daily life (scale > 29 of questionnaire of complaint on working memory (WMQ), and established deficit of working memory by one of the following criteria:
- •Index of working memory (IWM) of Wechsler Adult Intelligence Scale (WAIS-IV) < 85 or p < .05 between IWM and one of the WAIS-IV index;
- •Less than 70% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task as mental calculation;
- •Less than 89% correct responses on Brown-Peterson tasks test in the verbal modality with an interfering task of articulatory suppression;
- •Less than 70% correct responses on Brown-Peterson tasks test in the visuospatial modality with an interfering motor task.
- •Prior medical examination;
- •Correct vision after visual acuity correction;
- •Stable neurological or psychoactive treatment for at least 4 weeks, if applicable;
- •Able to move to the center where rehabilitation will be performed;
- •Covered by a health insurance;
- •Signed consent of patient or of the guardian.
排除标准
- •History of central nervous system disorder, or history of psychological disorder or substance abuse;
- •Prior specific cognitive rehabilitation of working memory;
- •Instrumental activities disabilities, cognitive disorder, behavioural disorders or major psychiatric disorder;
- •Major anxio-depressive syndrome or present psychiatric disorder which can interfere with experimental procedure or measured variables;
- •Pregnant or breastfeeding woman.
结局指标
主要结局
Proportions of simultaneous responders
时间窗: 3 months after the first rehabilitation session
A patient will be considered as a responder if he improves simultaneously on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task. Proportions will be calculated of patients simultaneously improving on the Working Memory Questionnaire (WMQ) and the Brown-Peterson Task: * increase of at least 12 points on WMQ scale, * at least 13% score improvement on the verbal or visuo-spatial Brown-Peterson Task.
次要结局
- Arithmetic resolution(At baseline, 3 months and 6 months)
- Social functioning assessement(At baseline, 3 months, 6 months and 9 months)
- Working Memory Questionnaire during rehabilitation program(At baseline, 3 months, 6 months and 9 months)
- Cognitive task of working memory(At baseline, 3 months, 6 months and 9 months)
- Non-targeted cognitive measurements(At baseline, 3 months and 6 months)
- Quality of life assessment(At baseline, 3 months, 6 months and 9 months)
- Acceptability(At baseline, 3 months and 6 months)