Cognitive Musical Screening and Therapeutic Innovation in Multiple Sclerosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHunter College of City University of New York

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 volunteers

Qualifiers

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

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • Musical tool (Ipsilon)

    Behavioral

    The musical tool to assess cognitive function

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Crossover design: Group 1 initial Intervention - Ipsilon musical tool1 intervention
Group B: Crossover design: Control arm starts without any intervention.0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 1 week and 2 weeks
2

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.

Time frame
Baseline, 1 week and 2 weeks
3

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.

Time frame
Baseline, 1 week and 2 weeks

Secondary outcomes

1

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.

Time frame
Baseline and 2 years
2

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.

Time frame
Baseline and 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunter College of City University of New York

Lead sponsor

The Cleveland Clinic

Collaborator

Genentech, Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: