Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis: Proposal for an Integrated Cognitive Treatment in a Telematic Format
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Paced Auditory Serial Addition Task (PASAT)
研究概览
简要总结
Non-Inferiority Study, Post-Market Clinical Investigation with a Device, Single-Blind Randomized Controlled Trial in a Cohort of Patients Diagnosed with Multiple Sclerosis (MS).
The aim of the study is to assess whether a computer-based cognitive treatment delivered via telerehabilitation produces effects from T0 to T1 that are not inferior to those of an in-person treatment on sustained attention in a cohort of patients with MS.
The secondary objective is to evaluate the effects of telerehabilitation compared to the same treatment delivered in person on attentional shifting, memory, executive functions, and daily functioning (including cognitive fatigue, quality of life, and mood) in patients with MS.
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 (Investigator)
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
- •Diagnosis of relapsing-remitting multiple sclerosis (RRMS), or primary progressive (PPMS) or secondary progressive (SPMS), defined by at least 3-6 months.
- •Age between 18 and 65 years.
- •Expanded Disability Status Scale (EDSS) between 3 and 5 to include patients with overall neurological disability from mild to moderate.
- •Presence of one or more of the following cognitive disorders (reported by the patient and subsequently confirmed through the Oxford Cognitive Screen-OCS):
- •Memory disorders
- •Attention disorders
- •Executive function disorders
- •Availability of internet at the patient's home necessary for the tele-rehabilitation procedures.
- •Adequate visual and auditory abilities to use the rehabilitation device.
排除标准
- •Presence of other neurological conditions;
- •Psychiatric disorders in medical history;
- •Alcohol and/or drug abuse;
- •Presence of uncorrected severe visual deficits.
研究组 & 干预措施
Telerehabilitation
Three hours of cognitive rehabilitation per week, carried out independently and remotely using a computerized device, which is pre-programmed according to the patient's specific needs.
干预措施: Cognitive treatment delivered via telerehabilitation. (Behavioral)
In-person treatment
Three hours of in-person cognitive rehabilitation per week using a computerized device. The participant will perform cognitive exercises on the computerized device in the presence of the therapist, who will activate the device (using credentials specifically created for them) and select the appropriate activity to administer at each session.
干预措施: In-person cognitive treatment. (Behavioral)
结局指标
主要结局
Paced Auditory Serial Addition Task (PASAT)
时间窗: The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen
In the Paced Auditory Serial Addition Task (PASAT), the patient listens to a recorded voice reading a series of numbers at regular intervals. They must mentally add each number to the one immediately preceding it and respond orally. The test assesses sustained attention, working memory, and processing speed. The maximum score, usually 60, corresponds to the number of correct responses, with higher scores indicating better cognitive performance.
次要结局
- Trail Making Test Part A (TMT-A)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Trail Making Test Part B (TMT-B)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Symbol Digit Modalities Test(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Modified Five Point Test (MFPT)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- "Learning" subtest of the Rivermead Behavioural Memory Test-3 (RBMT-3)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Phonemic Verbal Fluency Test(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Test of Attentional Performance (TAP)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Modified Fatigue Impact Scale (MFIS)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Multiple Sclerosis Quality of Life 54 (MSQOL-54)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
- Depression, Anxiety, and Stress Scale (DASS)(The test is administered before the treatment, then after eight weeks of treatment, and finally two months after the end of the treatmen)
研究者
Valentina Varalta
Doctor
Universita di Verona