Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

NCT05984056 | Active Not Recruiting

• 1 other identifier: 22-941
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neurological Disorder

Keywords

Dementia; Parkinson's disease; Stroke; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Pathology progression

  At the time of study completion, a participant will be considered to show "Pathology progression" if they fulfill either of the two conditions: * Clinically diagnosed with any of the above four conditions * Show the following changes compared to the baseline: * Stroke: Asymptomatic cortical infarct or further increase in white matter disease MRI changes * Epilepsy: Increase in burden (per hour) of Spikes/Sharp Waves/Polyspikes or electrographic seizure on EEG * Movement Disorder: \>4 points increase on modified Unified Parkinson's Disease Rating Scale (UPDRS) administered remotely * Dementia: Increase in number of domain testing ≤ 1.5 SD or drop in scores \< 2SD

  12 months

Secondary Outcomes (6)

• Quality of Life in Neurological Disorders (Neuro QoL)

  12 months

• PHQ8 (Patient Health Questionnaire)

  12 months

• Generalized Anxiety Disorder Questionnaire-7 (GAD-7)

  12 months

• General Self-Efficacy Scale (GSE)

  12 months

• Perceived Stress Scale (PSS-10)

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.

Behavioral: Multidisciplinary lifestyle interventions

Control

NO INTERVENTION

No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.

Interventions

Multidisciplinary lifestyle interventions BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Participants who are actively (at the time of enrollment) engaged in 2 or more of the study interventions.
• 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.
• 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.
• Participants who are currently pregnant or less than six weeks postpartum
• Participants with significant hearing loss
• Participants with severe impairment of vision/ blindness
• Participants who require a legally authorized representative (LAR) or lack the capacity to consent for themselves

Sponsors & Collaborators

• Vineet Punia MD: lead
• Ohio Department of higher education: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (11)

• Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.

  PMID: 30291317 BACKGROUND

• Marcason W. What Are the Components to the MIND Diet? J Acad Nutr Diet. 2015 Oct;115(10):1744. doi: 10.1016/j.jand.2015.08.002. No abstract available.

  PMID: 26407649 BACKGROUND

• Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.

  PMID: 26086182 BACKGROUND

• Dhana K, James BD, Agarwal P, Aggarwal NT, Cherian LJ, Leurgans SE, Barnes LL, Bennett DA, Schneider JA. MIND Diet, Common Brain Pathologies, and Cognition in Community-Dwelling Older Adults. J Alzheimers Dis. 2021;83(2):683-692. doi: 10.3233/JAD-210107.

  PMID: 34334393 BACKGROUND

• Jin B, Krishnan B, Adler S, Wagstyl K, Hu W, Jones S, Najm I, Alexopoulos A, Zhang K, Zhang J, Ding M, Wang S; Pediatric Imaging, Neurocognition, and Genetics Study; Wang ZI. Automated detection of focal cortical dysplasia type II with surface-based magnetic resonance imaging postprocessing and machine learning. Epilepsia. 2018 May;59(5):982-992. doi: 10.1111/epi.14064. Epub 2018 Apr 10.

  PMID: 29637549 BACKGROUND

• Panda A, Mehta BB, Coppo S, Jiang Y, Ma D, Seiberlich N, Griswold MA, Gulani V. Magnetic Resonance Fingerprinting-An Overview. Curr Opin Biomed Eng. 2017 Sep;3:56-66. doi: 10.1016/j.cobme.2017.11.001.

  PMID: 29868647 BACKGROUND

• Wik L, Nordberg N, Broberg J, Bjorkesten J, Assarsson E, Henriksson S, Grundberg I, Pettersson E, Westerberg C, Liljeroth E, Falck A, Lundberg M. Proximity Extension Assay in Combination with Next-Generation Sequencing for High-throughput Proteome-wide Analysis. Mol Cell Proteomics. 2021;20:100168. doi: 10.1016/j.mcpro.2021.100168. Epub 2021 Oct 27.

  PMID: 34715355 BACKGROUND

• Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.

  PMID: 25771249 BACKGROUND

• Moll van Charante EP, Richard E, Eurelings LS, van Dalen JW, Ligthart SA, van Bussel EF, Hoevenaar-Blom MP, Vermeulen M, van Gool WA. Effectiveness of a 6-year multidomain vascular care intervention to prevent dementia (preDIVA): a cluster-randomised controlled trial. Lancet. 2016 Aug 20;388(10046):797-805. doi: 10.1016/S0140-6736(16)30950-3. Epub 2016 Jul 26.

  PMID: 27474376 BACKGROUND

• Andrieu S, Guyonnet S, Coley N, Cantet C, Bonnefoy M, Bordes S, Bories L, Cufi MN, Dantoine T, Dartigues JF, Desclaux F, Gabelle A, Gasnier Y, Pesce A, Sudres K, Touchon J, Robert P, Rouaud O, Legrand P, Payoux P, Caubere JP, Weiner M, Carrie I, Ousset PJ, Vellas B; MAPT Study Group. Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial. Lancet Neurol. 2017 May;16(5):377-389. doi: 10.1016/S1474-4422(17)30040-6. Epub 2017 Mar 27.

  PMID: 28359749 BACKGROUND

• Taylor S, Sachdeva S, Darling S, Arrotta K, Gallagher L, Supan A, Shipta G, Perko J, Bar J, James J, Petschek I, Lioi A, Kundu S, Ellison L, Bekris LM, Willard B, Sangwan N, Mata I, Fernandez H, Katzan I, Conway D, Pillai J, Leverenz J, Busch RM, Floden D, Saper R, Barnard J, Machado A, Najm I, Punia V. Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol. Neurol Res Pract. 2024 Aug 1;6(1):39. doi: 10.1186/s42466-024-00334-3.

  PMID: 39085927 DERIVED

Related Links

• Cleveland Clinic Brain Study 2022
• Reale A. Cleveland Clinic Launches First-of-its-Kind Study to Assess Impact of Lifestyle Interventions to Control Epileptic Seizures 2022 \[cited 2022\].
• Reale A. Cleveland Clinic and Brooks Automation Open State-of-the-Art BioRepository in Fairfax Neighborhood 2021 \[cited 2022\].

MeSH Terms

Conditions

Nervous System Diseases; Dementia; Parkinson Disease; Stroke; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vineet Punia, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: July 13, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)