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ACTIVE NOT RECRUITING

NCT05984056

Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

Sponsor: Vineet Punia MD

View on ClinicalTrials.gov

Summary

This clinical trial aims to test the impact of multidisciplinary lifestyle interventions (MLI) in neurologically healthy but at-risk individuals. It aims to find out: * if giving four different kinds of lifestyle intervention and education slows down or reverses the expression of neurological disorder or their biomarkers. * new biomarkers that either help in the early detection of neurological disease or identify the impact of various lifestyle interventions combined. Participants will be randomized to the intervention or observation arm. Various biological samples and tests, along with survey questionnaires, will be performed at the time of entering the study, at 12 weeks after enrollment, and then at the end of the study at 12 months. * Intervention arm: Participants will receive weekly, instructor-led intervention sessions (virtual group sessions) for 12 weeks. After the 12-week mark, participants will be encouraged to practice what they learned for nine more months. * Observation arm: The intervention group will be compared to another group that did not get the intervention

Official title: Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2023-07-13

Completion Date

2026-06

Last Updated

2025-07-08

Healthy Volunteers

Yes

Conditions

Neurological Disorder

Interventions

BEHAVIORAL

Multidisciplinary lifestyle interventions

Multidisciplinary lifestyle interventions (Brain health training, Yoga, Music therapy, and the MINDS diet education)

Inclusion Criteria: 1. Participants must be enrolled in Cleveland Clinic Brain Study (CCBS). CCBS is a prospective non-interventional study platform for the hyper characterization of the brain and body systems changes (blood, cardio-vascular, voice, visual, cognitive, digestive, brain structure, and neurophysiology) in neurologically healthy individuals 50 years and older. All individuals undergo periodic and thorough neurological assessments, blood tests, and cardiac, neurocognitive, imaging, vision, and neurophysiological testing. 2. CCBS participants who do not have a clinical neurological disease (except headache) but show signs of being at risk of developing one of the four conditions based on the below criteria: * Stroke: MRI changes consistent with moderate-severe white matter disease on Fazekas Scale * Epilepsy: Spikes/Poylspikes/ Sharp Waves on EEG * Movement Disorder: Hyposmia on U. Penn Smell Identification Test (UPSIT \<10 percentile based on age) * Dementia: Auditory Verbal Learning Test (AVLT) Trial 1-5 total or Trial 7 scoring \<=1.5 SD and subjective memory on BACH score (proprietary test) 0-40 Exclusion Criteria: 1. Participants who are actively (at the time of enrollment) engaged in 2 or more of the study interventions. 2. Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, cannot safely or effectively participate in the study. 3. Participants undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that, in an investigator's opinion, would impact study participation. 4. Participants who are currently pregnant or less than six weeks postpartum 5. Participants with significant hearing loss 6. Participants with severe impairment of vision/ blindness 7. Participants who require a legally authorized representative (LAR) or lack the capacity to consent for themselves

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States