Multiple SclerosisMSNCT07552428
Cognitive Musical Screening and Therapeutic Innovation in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Hunter College of City University of New York.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Musical tool (Ipsilon)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple sclerosis
Who may be able to join
- diagnosed with multip[le sclerosis (MS)
- aged 18 and older
- speak fluent English
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
William El Samuels, PhD contact
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Musical tool (Ipsilon)
- Keywords
- MS, Cognitive Function, Musical Tool
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical tool (Ipsilon)Behavioural
The musical tool to assess cognitive function
| Study group | Role | What they receive |
|---|---|---|
| Crossover design: Group 1 initial Intervention - Ipsilon musical tool | Group 1 starts with the musical tool for 15 minutes x 7 days Receives: Behavioral: Musical tool (Ipsilon) | |
| Crossover design: Control arm starts without any intervention. | The control arm starts with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 week and 2 weeks
Secondary outcomes (2)
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.
Measured: Baseline and 2 years
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.
Measured: Baseline and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Rachel Galioto, PhD, Principal investigator, Cleveland Clinic, MS Mellen CenterAliza Ben-Zacharia, PhD, DNP, Principal investigator, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552428
- Sponsor's protocol ID
- 2026-0121-Hunter
- Other IDs
- ML46353
- Acronym
- MS
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Musical Screening and Therapeutic Innovation: A Crossover Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT07552428
- Acronym / sponsor ID
- MS / 2026-0121-Hunter
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Cognitive Function, Musical Tool
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Genentech, Inc.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover design: Group 1 initial Intervention - Ipsilon musical tool | – | Behavioral: Musical tool (Ipsilon)Group 1 starts with the musical tool for 15 minutes x 7 days |
| Crossover design: Control arm starts without any intervention. | – | –The control arm starts with no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple sclerosis
Key inclusion criteria (3 listed)
- diagnosed with multip[le sclerosis (MS)
- aged 18 and older
- speak fluent English
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Musical tool (Ipsilon)The musical tool to assess cognitive function | Behavioural | Crossover design: Group 1 initial Intervention - Ipsilon musical tool |
Primary outcome
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.
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.
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.
2 secondary outcomes
Working Difficulties
Time frame: Baseline and 2 years
Quality of life based on Multiple Sclerosis International Quality of Life questionnaire (MusiQoL)
Time frame: Baseline and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William El Samuels, PhD contact
Rachel Galioto, PhD principal investigator
Cleveland Clinic, MS Mellen Center
Aliza Ben-Zacharia, PhD, DNP principal investigator
Hunter College of City University of New York
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Hunter College of City University of New York.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aliza Ben-Zacharia, PhD, DNP (16462262616, ab1288@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function by the MInimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) (time frame: Baseline, 1 week and 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.