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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hunter College of City University of New York

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Genentech, Inc.
The Cleveland Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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