Brain Reorganization After Serious Game -Based Cognitive Rehabilitation in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Mean activation of the brain region involved in the functional network
研究概览
简要总结
This prospective, interventional, longitudinal, multicentre study aims to evaluate the impact of the "Serious game", an innovative cognitive remediation tool on brain reorganization in Multiple sclerosis patients, using functional Magnetic resonance imaging (MRI). The serious game is a tool combining the motivational mechanisms of video games with cognitive remediation techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •People with relapsing-remitting or progressive MS defined according to the 2010 revised McDonald criteria [56]
- •Cognitive complaints and deficits in at least one score on the initial neuropsychological examination (<5th percentile of the reference group)
- •Aged between ≥ 18 and ≤ 65 years
- •No defined relapse for at least 6 weeks
- •At least 4 weeks since a corticosteroid bolus
- •Patient with an internet connection
- •Patient covered by social security
- •Signed informed consent
排除标准
- •Claustrophobia preventing MRI;
- •Contraindication to MRI;
- •Wearing fixed dental braces;
- •Unable to receive oral and written information;
- •Unable to use the software (due in particular to motor and/or sensory difficulties);
- •Neurological or psychiatric comorbidity, other than MS and anxiety-depression syndrome,
- •Patient with severe anxiety-depression syndrome (BDI-FS > 10),
- •Pregnant or breastfeeding women
- •Taking neuroleptic treatment
- •Person under guardianship or curatorship
- •Person deprived of liberty
研究组 & 干预措施
Serious Game-based cognitive rehabilitation in multiple sclerosis patients
Specifically for the study, patients will undergo two morphological and functional MRI scans (at rest and during activation) on the 3T MRI scanner at St Philibert Hospital at M0 and M4.
In addition, two neuropsychological assessments will be carried out specifically at M0 and M4. The additional time required to complete these examinations is approximately 2½ hours.
干预措施: Serious Game (Other)
结局指标
主要结局
Mean activation of the brain region involved in the functional network
时间窗: 5 months
The mean activation of each brain region involved in the functional network, will be measured using by functional MRI (fMRI) in patients with relapsing-remitting or progressive MS before and after Serious game. For each participant, a generalized linear model will be applied with the activation paradigm as a regressor to generate individual brain activation maps related to the functional task. The average activation values extracted from the regions of interest within the functional network will serve as the quantitative measure for statistical analyses.
次要结局
未报告次要终点