About this trial
This pilot study evaluates the effectiveness of screening and improving cognitive function in patients with multiple sclerosis (MS) using a musical tool, the Ipsilon. The Ipsilon performance will be compared with established neuropsychological assessments, including the Minimal Assessment of Cognitive Function in MS (MACFIMS) and the Processing Speed Test (PST). Thirty-two participants will be enrolled in a crossover design: half will complete the Ipsilon musical test for 15 minutes daily for seven consecutive days, while the other half will begin with no intervention before switching sequences. Participants will undergo screening for depression, colorblindness, musical background, and upper extremity function. Primary outcomes include evaluating whether the Ipsilon more reliably predicts cognitive domains measured by MACFIMS than the PST and assessing its potential to improve cognitive function. Secondary outcomes will examine associations with work functioning and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosed with multip[le sclerosis (MS)
aged 18 and older
speak fluent English
Disqualifiers
Mental incapacity/major depression or psychiatric illness as determined by the neurology team and a score ≥11 on the Patient Health Questionnaire-9 (PHQ9)
Neurological conditions (other than MS) or medical illnesses that affect cognitive function (i.e., Alzheimer's disease, stroke)
On psychoactive medications or medications that may influence cognition (e.g. Aricept, Adderall) or active substance abuse
Professional musician (≥2 years formal training in last 5 years or ≥ 2 hours/week of currently playing a musical instrument)
Trial population
Patients with multiple sclerosis
Trial design
Case-crossover
Prospective
Treatments tested in this trial
Musical tool (Ipsilon)
BehavioralThe musical tool to assess cognitive function
Treatment groups
Trial outcomes
Primary outcomes
Cognitive function by the MInimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS)
The cognitive function of patients with MS will be screened and assessed using the minimal assessment of cognitive function in multiple sclerosis (MACFIMS) that assesses 6 cognitive domains: processing speed, executive functions, visuospatial skills, language, verbal memory, and visual memory.
Cognitive function by the Ipsilon Musical Tool
The cognitive function assessed using the Ipsilon musical tool follows the three domains of piano playing: the visual recognition of the visual stimuli, visuo-spatial-motor comprehension of the visual stimuli, and motor execution. The Ipsilon tests memory, attention, executive functioning and visuospatial domains.
Cognitive function by the Processing Speed Test (PST)
The cognitive function will be assessed using the processing speed test (PST). The PST measures MS-related information processing speed. The results of the PST are available as raw scores, and z-scores standardized by age and education compared to MS peers.
Secondary outcomes
Working Difficulties
Each participant will be evaluated at baseline and at end of study about their work difficulties using a valid and reliable tool. The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ) is a 23-item self-report scale assessing the level of perceived workplace difficulties in patients with MS in 12 domains. These include general cognitive difficulties, prospective memory difficulties, fatigue, non-supportive workplace, low self-esteem, interpersonal difficulties, mobility difficulties, bladder/bowel difficulties, pain/temperature difficulties, workplace inaccessibility, work/home balance difficulties, and financial security concerns.
Quality of life based on Multiple Sclerosis International Quality of Life questionnaire (MusiQoL)
Each participant will answer a questionnaire about their quality of life measured based on the Multiple Sclerosis International Quality of Life questionnaire (MusiQoL). The MusiQoL is a tool validated in MS and is focuses on health and daily activities.
Locations
Sponsors and contacts
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Hunter College of City University of New York
Lead sponsor
The Cleveland Clinic
Collaborator
Genentech, Inc.
Collaborator
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