Cognitive Musical Screening and Therapeutic Innovation in Multiple Sclerosis (MS)

April 20, 2026 updated by: Hunter College of City University of New York

Neurocognitive Musical Screening and Therapeutic Innovation: A Crossover Randomized Controlled Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This pilot study assesses the screening of cognitive function and potentially cognitive function improvement in patients with multiple sclerosis using a musical tool, the Ipsilon; comparing it to a neuropsychological cognitive battery, the Minimal Assessment of Cognitive Function in MS (MACFIMS) and the Processing Speed test (PST). Patients (n=32) will follow a crossover design where 50% of patients will start with completing the Ipsilon musical test daily for 15 minutes for consecutive 7 days and 50% will start with no intervention and then they will switch over to the second sequence. This pilot study will include 15-18 months of rolling recruitment beginning in month 3 after IRB approval and protocol training. The study leverages Cognitive Load Theory to guide the cognitive assessments, ensuring that the crossover of the Ipsilon musical tool mitigate any carryover and practice effects. The study participants will undergo psychiatric screening using the Patient Health Questionnaire-9 (PHQ9) given the significant impact of mental health on cognitive performance. Participants who screen positively for any mood disorders (presenting with a score of ≥11 on the PHQ9) will be directed to the psychologist or social worker within the MS center, and those at high risk will receive referrals to either a psychiatrist or the psychiatric emergency department. Additionally, patients will be screened for colorblindness, considering the diverse colors featured on the Ipsilon tool, and will also be queried about their musical backgrounds given the musical notes of the tool. In addition, the patients' upper extremity motor function will be evaluated using the 9-hole peg test53 to assess their physical capacity to successfully complete both the Ipsilon and the PST. The primary first outcome is the determination of whether the Ipsilon musical tool more reliably predicts the various domains of cognitive functioning measured by the MACFIMS than the PST (Aim 1a). The primary second outcome is the ability of the Ipsilon tool to improve and rehabilitate cognitive function (Aim 1b). In addition, we will investigate the ability of the Ipsilon musical tool and the PST to detect and predict work difficulties among patients with MS and its association with quality of life (secondary outcome). Utilizing tablet/iPad technology for administering these cognitive tools facilitates standardized data collection. The approach to recruit participants from the MS center (Cleveland Clinic) who has diverse ethnic representations underscores the study's aims for comprehensive demographic inclusion, ensuring a more representative participant pool. This project will employ a simple randomization method to determine the crossover sequence of administering the Ipsilon musical tool vs. no assessment.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple sclerosis

Description

Inclusion Criteria:

  • diagnosed with multip[le sclerosis (MS)
  • aged 18 and older
  • speak fluent English

Exclusion Criteria:

  • 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)
  • Severe vision/hearing impairments precluding assessments: color blindness, considering the diverse colors featured on the Ipsilon tool.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Crossover design: Group 1 initial Intervention - Ipsilon musical tool
Group 1 starts with the musical tool for 15 minutes x 7 days
Behavioral: Musical tool (Ipsilon)
The musical tool to assess cognitive function
Crossover design: Control arm starts without any intervention.
The control arm starts with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive function by the MInimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS)
Time Frame: Baseline, 1 week and 2 weeks
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.
Baseline, 1 week and 2 weeks
Cognitive function by the Ipsilon Musical Tool
Time Frame: Baseline, 1 week and 2 weeks
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.
Baseline, 1 week and 2 weeks
Cognitive function by the Processing Speed Test (PST)
Time Frame: Baseline, 1 week and 2 weeks
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.
Baseline, 1 week and 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Difficulties
Time Frame: Baseline and 2 years
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.
Baseline and 2 years
Quality of life based on Multiple Sclerosis International Quality of Life questionnaire (MusiQoL)
Time Frame: Baseline and 2 years
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.
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hunter College of City University of New York

Collaborators

Genentech, Inc.
The Cleveland Clinic

Investigators

  • Principal Investigator: Rachel Galioto, PhD, Cleveland Clinic, MS Mellen Center
  • Principal Investigator: Aliza Ben-Zacharia, PhD, DNP, Hunter College of City University of New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 13, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-0121-Hunter
  • ML46353 (Other Grant/Funding Number: Genentech)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make IPD available. Data dictionary (a description of the variables, or types of data, collected for each individual) will be provided so that the data can be fully interpreted.

IPD Sharing Time Frame

1/1/2029 till 1/1/2030

IPD Sharing Access Criteria

Researchers will be able to access the protocol data, and analysis plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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