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

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.