Cognitive Musical Screening and Therapeutic Innovation in Multiple Sclerosis

NCT07552428 | Not Yet Recruiting

• 2 other identifiers: 2026-0121-HunterML46353
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

MS; Cognitive Function; Musical Tool

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, 1 week and 2 weeks

• 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.

  Baseline, 1 week and 2 weeks

• 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.

  Baseline, 1 week and 2 weeks

Secondary Outcomes (2)

• Working Difficulties

  Baseline and 2 years

• Quality of life based on Multiple Sclerosis International Quality of Life questionnaire (MusiQoL)

  Baseline and 2 years

Study Arms (2)

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)

Crossover design: Control arm starts without any intervention.

The control arm starts with no intervention.

Interventions

Musical tool (Ipsilon) BEHAVIORAL

The musical tool to assess cognitive function

Crossover design: Group 1 initial Intervention - Ipsilon musical tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple sclerosis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• The Cleveland Clinic: collaborator
• Genentech, Inc.: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rachel Galioto, PhD

  Cleveland Clinic, MS Mellen Center

  PRINCIPAL INVESTIGATOR

• Aliza Ben-Zacharia, PhD, DNP

  Hunter College of City University of New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliza Ben-Zacharia, PhD, DNP

CONTACT

16462262616; ab1288@hunter.cuny.edu

William El Samuels, PhD

CONTACT

ws1114@hunter.cuny.edu

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1/1/2029 till 1/1/2030
• Access Criteria: Researchers will be able to access the protocol data, and analysis plan.