Cognitive Rehabilitation Training for People With Multiple Sclerosis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants with improved Information processing speed
研究概览
简要总结
Cognitive rehabilitation is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects daily, family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, the most notable deficit being information processing speed, learning and memory and executive function, there is an obvious need for effective cognitive rehabilitation.
The proposed study will be a randomized controlled single-blinded trial with treatment and wait-list control group. The treatment group will be administered the Goal Management Training (GMT) program; the wait-list control group will be given usual care by their neurologist.
Intervention details:
The treatment group will receive in-person computerized cognitive rehabilitation (using the GMT program) (virtual training is optional) for 5 weeks (40-min sessions, twice per week), session will be tailored according to patient cognitive concerns at index assessment, and level of ability.
The wait list control group, will not receive treatment
Our primary outcome is information processing speed, secondary aims include learning and memory, and executive function. The minimal assessment of cognitive function in MS (MACFIMS) will be utilized to assess cognitive function. Additionally, tertiary aims include the following patient reported outcomes (PROs) will be collected: the hospital anxiety and depression scale (HADS), the modified fatigue impact scale (MFIS), the multiple sclerosis impact scale (MSIS-29), and the European quality of life (EQ-5D-5L) scale, to capture level of depression and anxiety, fatigue, impact of MS and quality of life.
Cognitive performance of all patients in both groups will be assessed at baseline, immediate post-5-week assessment, and at post 6-month follow-up assessment. We hypothesized that, compared to persons in the wait-list group, the participants receiving the GMT intervention will demonstrate significant improvements across all cognitive measures.
The wait-list control group will be given the option to receive the GMT intervention after the 6 months follow-up is complete. The individuals in the treatment group, wishing to continue with the GMT program, will be given a referral by Dr. Feinstein to a GMT certified therapist.
详细描述
Background:
Multiple sclerosis (MS) is a chronic disabling disease of the central nervous system, with symptom onset commonly occurring between the ages of 20 to 40 years old; with females being at a higher risk of developing MS than men. Cognitive impairment (CI) in the last decade has been acknowledged as a prevalent core feature of the MS clinical picture, along with mobility issues. Cognitive impairment affects up to 44.5 % of people with relapsing remitting MS (RRMS), 79.4 % in secondary progressive MS (SP), and up to 91.3 % in people with primary progressive MS. The most prominent deficits reported being information processing speed, learning and memory and executive function. Cognitive decline has been found to directly affect the quality of life of people with MS, impacting participation in social activities, driving abilities, employment productivity, and task of daily living. Currently there is no approved medication for the treatment of CI in MS, patients and their clinicians are left with basically symptomatic treatments. In the last decade there has been an increase in developing non-pharmacological rehabilitation treatment to reverse or to at least slow down the progression of cognitive decline with cognitive rehabilitation.
KEYWORDS Learning and memory; executive function; information processing speed; Goal Management Training; multiple sclerosis.
Proposal and aims:
Cognitive rehabilitation (CR) is designed to enhance a person's capacity to process and interpret information and improve their ability to function in all aspects of family and community life. Given the clear and consistent documentation of cognitive deficits in persons with MS, there is an obvious need for effective cognitive rehabilitation. A leading cognitive rehabilitation program called Goal Management Training® (GMT), has been used as an effective treatment for a variety of patient populations, including traumatic brain injury, stroke, schizophrenia, attention deficit hyperactivity disorder and multiple sclerosis for the treatment of cognitive deficits specifically executive function, learning & memory, and information processing speed.
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)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A define diagnosis of multiple sclerosis (which will include clinically isolate syndrome, radiologically isolated syndrome and neuromyelitis optica spectrum disorder).
- •A performance below 1.5 or 2 standard deviations (SD) compared to the normative mean in at least 20-30% of the test parameters.
- •Corrected near vision of 20/70 or better (to see test material)
排除标准
- •Exclude persons with a history of central nervous system disease other than MS
- •Use of illicit drugs, phencyclidine (PCP), Lysergic acid diethylamide (LSD), stimulants, amphetamines, barbiturates, etc. (Cannabis use is accepted)
- •Psychotic symptoms, bipolar disorder, schizophrenia
- •Exclude persons who have used steroids within the past 3 months
- •Exclude persons unable or unwilling to travel to the Centre or requires transportation by ambulance.
结局指标
主要结局
Number of participants with improved Information processing speed
时间窗: 5 weeks immediate post assessment, and 6 months post assessment
The Symbol Digit Modality Test (SDMT), will be use to measure changes in processing speed. A poor SDMT score tells us that cognitive decline occurred. Scoring involves summing the number of correct substitutions within the 90 second interval (max = 110). Higher scores means a better outcome.
次要结局
- Number of participants with improved executive function(5 weeks immediate post assessment, and 6 months post assessment)
- Number of participants with improved learning and memory(5 weeks immediate post assessment, and 6 months post assessment)
研究者
Dr. Anthony Feinstein
Lead principal investigator
Sunnybrook Health Sciences Centre