Randomised Controlled Clinical Trial of Cognitive Rehabilitation in Multiple Sclerosis
关键词
抽象
描述
: Multiple Sclerosis (MS) is the most frequent disabling neurological disease in young adults. Over the past two decades, cognitive impairment in MS has received increasing interest. Although for a long time described in MS text books, it has been underestimated until recently. It is now accepted as an important feature of MS with a high impact on working and social abilities. The cognitive disorders in MS are dominated by a slowdown in information processing speed (IPS), as well as disturbances of attention and memory. The nature of cognitive findings suggest that the impairments depend on the integrity of large-scale cortical integrative processes, which involve long-distance white matter projections which can be impaired due to diffuse demyelinating injury in patients with MS. At the early stages of MS there is increasing evidence that neuroplasticity, the ability of the brain to respond to various insults, allows adaptive reorganization of cognitive functions to limit impairment, despite widespread tissue damage. Recently, we showed that at the early stages of RRMS compensatory capacities are relatively maintained, especially in highly-educated patients suggesting that cognitive training might be useful. The requirement of cerebral compensatory mechanisms to perform the cognitive tests was postulated in MS patients on the basis of functional MRI (fMRI) studies. By using a go/no go task of increasing complexity in a fMRI study in RRMS patients, we observed that a limitation of this compensatory cerebral recruitment appears when the attentional solicitations reach a particular level of difficulty. We postulate that a cognitive training program may help to maintain these compensatory capacities. Therefore, we propose to evaluate the effect of the program on brain activation using a task with several levels of attention requirement (increased attention load) by using fMRI and to evaluate in parallel its clinical effect and its impact in daily activities.
日期
| 最后验证: | 01/31/2016 |
| 首次提交: | 09/21/2010 |
| 提交的预估入学人数: | 09/21/2010 |
| 首次发布: | 09/22/2010 |
| 上次提交的更新: | 02/07/2016 |
| 最近更新发布: | 02/08/2016 |
| 实际学习开始日期: | 04/30/2011 |
| 预计主要完成日期: | 06/30/2015 |
| 预计完成日期: | 01/31/2016 |
状况或疾病
干预/治疗
Behavioral: group A
Behavioral: Groupe B : non specific rehabilitation
Other: group C
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: group A specific cognitive rehabilitation | Behavioral: group A Individual rehabilitation procedures will be focused on attention, executive functions, IPS and working memory. The program will be tailored to each patient cognitive status depending on the impairments identified during the initial assessment while maintaining a systematic work on attention and executive functions. A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed. Sessions will include varied exercises according to complexity and presentation modality, using computerized and "paper-and-pencil" tasks and metacognitive training. Work will be progressive, depending on the progresses achieved (increase complexity and intensity of the exercises according to success at the previous level of exercises). |
| Active Comparator: Groupe B : non specific rehabilitation | Behavioral: Groupe B : non specific rehabilitation A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed by group composed to 5 patients |
| Other: group C group C for MRI, neuropsychological and ecological assessments | Other: group C no intervention |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: patients - male or female relapsing remitting or secondary progressive or primary progressive Multiple sclerosis patients according to Polman et al. (2005), - age 18-55; disease duration >6 months and ≤15 years, - right handed, Patients will be eligible for randomization (cognitive inclusion criterion) if they performed worse than : - 2 scores <1 standard deviation (SD) on the scores evaluating information processing speed and attention (IPS-Attention) and 1 score <1DS on other tests assessing executive functions (EF) and working memory (WM). or - if they performed worse than 2 scores <1 SD on the 5 tests of information processing speed, attention and executive function (SDMT, Stroop and TMT battery GREFEX, and divided attention substests (TAP) and 1 score <1DS on other tests assessing information processing speed, and executive and attention functions (IPS / FAE) and working memory (WM). healthy volunteers - male or female, - age 18-55 matched for age, gender and education - Accepting to participate and signing the informed consent - affiliated to french social security Exclusion Criteria: - existing other neurological or psychiatric disorder, visual, oculomotor, auditory and motor impairments precluding ability to perform computerized tasks and the driving simulator tasks, - prior history of addictive behaviour, - MS attack in the 2 months preceding the screening, - corticosteroid pulse therapy within 2 months preceding screening, - severe cognitive deficits or dementia (MMS<27), moderate to severe visuospatial incapacity (type IV or V at the Rey figure score < 28), moderate to severe depression (BDI >27), - Participant without driving licence |
结果
主要结果指标
1. Comparison between groups concerning the z cognitive global executive z score . [after 4 months (M4)]
次要成果指标
1. Comparison of brain activation in the treated group versus control group at the fourth condition. [4 and 8 months]
2. Comparison between groups concerning the z score of the SDMT [4 and 8 months]
3. Comparison between groups of the daily-life cognitive questionnaire scores [at M4 and M8]
4. Comparison between groups concerning the z cognitive global executive z score [8 months]
5. Clinical Global impression of patients [4 and 8 months]
