{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T06:16:25Z","timestamp":1773296185338,"version":"3.50.1"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100016942","name":"Ohio Department of Higher Education","doi-asserted-by":"publisher","award":["ODHE2212PV"],"award-info":[{"award-number":["ODHE2212PV"]}],"id":[{"id":"10.13039\/100016942","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Neurol. Res. Pract."],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Introduction<\/jats:title>\n                <jats:p>Given the prevalence and staggering cost of neurological disorders, there is dire need for effective early detection and intervention tools. Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders. The objectives of this protocol are (1) to test the impact of MLI on the progression of neurological disorders and (2) to identify multi-omic biomarkers for early stages of neurological disease and the impact of MLIs on these biomarkers.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods and analysis<\/jats:title>\n                <jats:p>We present the Multidisciplinary lifestyle Interventions for Neurological Disorders during the Silent phase (MINDS) protocol, a randomized controlled trial of MLI in neurologically healthy older adults (\u2265\u200950 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson\u2019s Disease, or Alzheimer\u2019s disease and related dementias. Participants will be randomly assigned to intervention (<jats:italic>n<\/jats:italic>\u2009=\u2009100) or control (<jats:italic>n<\/jats:italic>\u2009=\u2009100) groups. The intervention group will receive 3 months of weekly 2-hour sessions on diet education, yoga, music therapy, and cognitive skills training. The participants\u2019 neurological health and engagement in relevant lifestyle practices will be assessed at regular intervals for 12 months. Neuroimaging and samples for multi-omic analyses will be collected at baseline, and at 3 months and 12 months after enrollment. Primary outcomes will be signs of progression of the neurological disorder risk that qualified them for study enrollment or a clinical diagnosis of the disorder. Secondary and exploratory outcomes will be based on self-reported health and multi-omic data. Data analysis will include between-group and longitudinal within-group analyses.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Perspectives<\/jats:title>\n                <jats:p>The MINDS protocol and trial aims to clarify the impact of MLI on the progression of neurological disorder risk or diagnosis in older adults and to identify biomarkers that can be used to confirm MLI efficacy. The ability to validate the impact of MLI on neurological disorder progression based on biomarker data allows the identification of individuals most likely to benefit from such therapies in the early stages of neurological disease.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The trial is registered on the National Institutes of Health (NIH) ClinicalTrials.gov (NCT05984056) site. It was registered on August 2nd, 2023. The trial has full approval of the Cleveland Clinic Internal Review Board.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s42466-024-00334-3","type":"journal-article","created":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T01:09:52Z","timestamp":1722474592000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol"],"prefix":"10.1186","volume":"6","author":[{"given":"Sara","family":"Taylor","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seerat","family":"Sachdeva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandra","family":"Darling","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kayela","family":"Arrotta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Gallagher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexis","family":"Supan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gabrielle","family":"Shipta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jim","family":"Perko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judi","family":"Bar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joe","family":"James","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iris","family":"Petschek","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony","family":"Lioi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suman","family":"Kundu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa","family":"Ellison","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lynn M.","family":"Bekris","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Belinda","family":"Willard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naseer","family":"Sangwan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ignacio","family":"Mata","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hubert","family":"Fernandez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene","family":"Katzan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Devon","family":"Conway","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jagan","family":"Pillai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Leverenz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robyn M.","family":"Busch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darlene","family":"Floden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Saper","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Barnard","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andre","family":"Machado","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Imad","family":"Najm","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0552-6736","authenticated-orcid":false,"given":"Vineet","family":"Punia","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,8,1]]},"reference":[{"key":"334_CR1","doi-asserted-by":"crossref","unstructured":"Feigin, V. L., Vos, T., Alahdab, F., Amit, A. M. L., B\u00e4rnighausen, T. W., Beghi, E. (2021). Burden of Neurological Disorders Across the US From 1990\u20132017. JAMA Neurol [Internet]. ;78(2):165. https:\/\/jamanetwork.com\/journals\/jamaneurology\/fullarticle\/27725792.","DOI":"10.1001\/jamaneurol.2020.4152"},{"key":"334_CR2","doi-asserted-by":"publisher","unstructured":"Ding, C., Wu, Y., Chen, X., Chen, Y., Wu, Z., Lin, Z. (2022). Global, regional, and national burden and attributable risk factors of neurological disorders: The Global Burden of Disease study 1990\u20132019. Front Public Health [Internet]. ;10. https:\/\/www.frontiersin.org\/articles\/https:\/\/doi.org\/10.3389\/fpubh.2022.952161\/full.","DOI":"10.3389\/fpubh.2022.952161\/full"},{"key":"334_CR3","doi-asserted-by":"crossref","unstructured":"Su\u00e1rez-Iglesias, D., Santos, L., Sanchez-Lastra, M. A., & Ay\u00e1n, C. (2022). Systematic review and meta-analysis of randomised controlled trials on the effects of yoga in people with Parkinson\u2019s disease (Vol. 44, pp. 6210\u20136229). Taylor and Francis Ltd. Disability and Rehabilitation.","DOI":"10.1080\/09638288.2021.1966522"},{"issue":"1","key":"334_CR4","doi-asserted-by":"publisher","first-page":"68","DOI":"10.5498\/wjp.v5.i1.68","volume":"5","author":"A Raglio","year":"2015","unstructured":"Raglio, A., Attardo, L., Gontero, G., Rollino, S., Groppo, E., & Granieri, E. (2015). Effects of music and music therapy on mood in neurological patients. World J Psychiatry, 5(1), 68\u201378.","journal-title":"World J Psychiatry"},{"issue":"21","key":"334_CR5","doi-asserted-by":"publisher","first-page":"1843","DOI":"10.1212\/WNL.0000000000002145","volume":"85","author":"IH Leung","year":"2015","unstructured":"Leung, I. H., Walton, C. C., Hallock, H., Simon Lewis, M. J., Valenzuela, M., & Lampit, A. (2015). Cognitive training in Parkinson disease: A systematic review and meta-analysis. Neurology, 85(21), 1843\u20131851.","journal-title":"Neurology"},{"key":"334_CR6","doi-asserted-by":"crossref","unstructured":"Zucchella, C., Sinforiani, E., Tamburin, S., Federico, A., Mantovani, E., Bernini, S., et al. (2018). The Multidisciplinary Approach to Alzheimer\u2019s Disease and Dementia. A narrative review of Non-pharmacological Treatment (Vol. 9). Frontiers Media S.A. Frontiers in Neurology.","DOI":"10.3389\/fneur.2018.01058"},{"key":"334_CR7","doi-asserted-by":"crossref","unstructured":"Bleibel, M., El Cheikh, A., Sadier, N. S., & Abou-Abbas, L. (2023). The effect of music therapy on cognitive functions in patients with Alzheimer\u2019s disease: A systematic review of randomized controlled trials (Vol. 15). BioMed Central Ltd. Alzheimer\u2019s Research and Therapy.","DOI":"10.1186\/s13195-023-01214-9"},{"issue":"7","key":"334_CR8","doi-asserted-by":"publisher","first-page":"602","DOI":"10.1056\/NEJMoa2302368","volume":"389","author":"LL Barnes","year":"2023","unstructured":"Barnes, L. L., Dhana, K., Liu, X., Carey, V. J., Ventrelle, J., Johnson, K., et al. (2023). Trial of the MIND Diet for Prevention of Cognitive decline in older persons. New England Journal of Medicine, 389(7), 602\u2013611.","journal-title":"New England Journal of Medicine"},{"key":"334_CR9","doi-asserted-by":"crossref","unstructured":"Feigin, V. L., Norrving, B., George, M. G., Foltz, J. L., Roth, G. A., & Mensah, G. A. (2016). Prevention of stroke: A strategic global imperative (Vol. 12, pp. 501\u2013512). Nature Publishing Group. Nature Reviews Neurology.","DOI":"10.1038\/nrneurol.2016.107"},{"issue":"3\u20134","key":"334_CR10","doi-asserted-by":"publisher","first-page":"150","DOI":"10.1159\/000367652","volume":"73","author":"H Sarikaya","year":"2015","unstructured":"Sarikaya, H., Ferro, J., & Arnold, M. (2015). Stroke prevention - medical and lifestyle measures. European Neurology, 73(3\u20134), 150\u2013157.","journal-title":"European Neurology"},{"key":"334_CR11","doi-asserted-by":"crossref","unstructured":"Yaffe, K., Vittinghoff, E., Dublin, S., Peltz, C. B., Fleckenstein, L. E., Rosenberg, D. E. (2023). Effect of Personalized Risk-Reduction Strategies on Cognition and Dementia Risk Profile Among Older Adults. JAMA Intern Med [Internet]. ; https:\/\/jamanetwork.com\/journals\/jamainternalmedicine\/fullarticle\/2811803.","DOI":"10.1001\/jamainternmed.2023.6279"},{"key":"334_CR12","unstructured":"Cleveland Clinic Brain Study [Internet] https:\/\/my.clevelandclinic.org\/departments\/neurological\/research-innovations\/brain-study."},{"key":"334_CR13","doi-asserted-by":"crossref","unstructured":"Gothe, N. P., & McAuley, E. (2015). Yoga and cognition: A Meta-analysis of chronic and Acute effects (Vol. 77, pp. 784\u2013797). Lippincott Williams and Wilkins. Psychosomatic Medicine.","DOI":"10.1097\/PSY.0000000000000218"},{"key":"334_CR14","doi-asserted-by":"crossref","unstructured":"Sihvonen, A. J., S\u00e4rk\u00e4m\u00f6, T., Leo, V., Tervaniemi, M., Altenm\u00fcller, E., & Soinila, S. (2017). Music-based interventions in neurological rehabilitation (Vol. 16, pp. 648\u2013660). Lancet Publishing Group. The Lancet Neurology.","DOI":"10.1016\/S1474-4422(17)30168-0"},{"issue":"18","key":"334_CR15","doi-asserted-by":"publisher","first-page":"868","DOI":"10.1212\/WNL.0000000000206797","volume":"100","author":"E Edwards","year":"2023","unstructured":"Edwards, E., St Hillaire-Clarke, C., Frankowski, D. W., Finkelstein, R., Cheever, T., Chen, W. G., et al. (2023). NIH Music-based intervention toolkit: Music-based interventions for Brain disorders of Aging. Neurology, 100(18), 868\u2013878.","journal-title":"Neurology"},{"key":"334_CR16","doi-asserted-by":"crossref","unstructured":"Kivipelto, M., Mangialasche, F., & Ngandu, T. (2018). Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease (Vol. 14, pp. 653\u2013666). Nature Publishing Group. Nature Reviews Neurology.","DOI":"10.1038\/s41582-018-0070-3"},{"key":"334_CR17","doi-asserted-by":"crossref","unstructured":"Mowszowski, L., Lampit, A., Walton, C. C., & Naismith, S. L. (2016). Strategy-based cognitive training for improving executive functions in older adults: A systematic review (Vol. 26, pp. 252\u2013270). Springer New York LLC. Neuropsychology Review.","DOI":"10.1007\/s11065-016-9329-x"},{"key":"334_CR18","doi-asserted-by":"crossref","unstructured":"Chan, A. W., Tetzlaff, J. M., G\u00f8tzsche, P. C., Altman, D. G., Mann, H., Berlin, J. A. (2013). SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. Bmj. ;346.","DOI":"10.1136\/bmj.e7586"},{"issue":"20","key":"334_CR19","doi-asserted-by":"publisher","first-page":"E2139","DOI":"10.1212\/WNL.0000000000009439","volume":"94","author":"MA Kural","year":"2020","unstructured":"Kural, M. A., Duez, L., Sejer Hansen, V., Larsson, P. G., Rampp, S., Schulz, R., et al. (2020). Criteria for defining interictal epileptiform discharges in EEG: A clinical validation study. Neurology, 94(20), E2139\u2013E2147.","journal-title":"Neurology"}],"container-title":["Neurological Research and Practice"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s42466-024-00334-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s42466-024-00334-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s42466-024-00334-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T01:10:37Z","timestamp":1722474637000},"score":1,"resource":{"primary":{"URL":"https:\/\/neurolrespract.biomedcentral.com\/articles\/10.1186\/s42466-024-00334-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,1]]},"references-count":19,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["334"],"URL":"https:\/\/doi.org\/10.1186\/s42466-024-00334-3","relation":{},"ISSN":["2524-3489"],"issn-type":[{"value":"2524-3489","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,1]]},"assertion":[{"value":"24 May 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 July 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 August 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"We used the SPIRIT reporting guidelines to write this report []. The Cleveland Clinic Institutional Review Board (IRB) has approved this study protocol (current protocol approved 2\/28\/2024, v7). All significant protocol modifications are approved by the primary investigator and submitted to the Institutional Review Board for review and approval prior to being enacted. Given the healthy status of enrolled participants and the preventative, low risk nature of the intervention, no data monitoring committee has been established. Only participants who consent to hear about research findings and other research studies in the CCBS consent process are contacted regarding participation eligibility in the present study. Research coordinators for the MINDS study obtain informed consent from eligible participants in the MINDS study. Participant data for eligible and enrolled participants are collected and stored in a secure data registry. Trial conduct and documentation are audited by a quality assurance compliance officer independent from the study team and subject to IRB monitoring and approval. Results from the study analyses will be published in academic journals and shared with the sponsor. The sponsor can, in turn, share the results with the public.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Vineet Punia is the PI of the MINDS study. He does not have any competing interests. Devon Conway has received research support paid to his institution from Biogen, Horizon, Bristol Myers Squibb, Novartis, EMD Serono and the Department of Defense. He has received consulting fees from Alexion, Bristol Myers Squibb, Novartis, and TG Therapeutics and speaking fees from Biogen. Robert Saper has received salary support from NIH for yoga-related studies and the Charles Shor Foundation. He has received royalties from UpToDate. Darlene Floden and Robyn Busch would like to disclose the potential for future distributions from Ceraxis Health, Inc. as inventors. The remaining authors have no competing interests to report.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"39"}}