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| ID | Type | Description | Link |
|---|---|---|---|
| ML46353 | Other Grant/Funding Number | Genentech |
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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover design: Group 1 initial Intervention - Ipsilon musical tool | Group 1 starts with the musical tool for 15 minutes x 7 days |
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| Crossover design: Control arm starts without any intervention. | The control arm starts with no intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Musical tool (Ipsilon) | Behavioral | The musical tool to assess cognitive function |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with multiple sclerosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aliza Ben-Zacharia, PhD, DNP | Contact | 16462262616 | ab1288@hunter.cuny.edu | |
| William El Samuels, PhD | Contact | ws1114@hunter.cuny.edu |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
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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.
1/1/2029 till 1/1/2030
Researchers will be able to access the protocol data, and analysis plan.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| 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. | Baseline and 2 years |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |