Multidisciplinary lifestyle interventions for neurological disorders during the Silent phase (MINDS) study: a multi-omics randomized controlled trial protocol.

Autor: Taylor S; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Sachdeva S; Dr. Sampurnanand Medical College, Jodhpur, Rajasthan, India., Darling S; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.; Arts & Medicine Department, Patient Experience, Cleveland Clinic, Cleveland, OH, USA., Arrotta K; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Gallagher L; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., Supan A; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., Shipta G; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., Perko J; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., Bar J; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., James J; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Petschek I; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Lioi A; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Kundu S; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Ellison L; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Bekris LM; Lerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA., Willard B; Lerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA., Sangwan N; Lerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA., Mata I; Lerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA., Fernandez H; Center for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Katzan I; Cerebrovascular Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Conway D; Mellen Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Pillai J; Neurological Institute, Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH, USA., Leverenz J; Neurological Institute, Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH, USA., Busch RM; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Floden D; Center for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Saper R; Primary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA., Barnard J; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA., Machado A; Center for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.; Department of Neurosurgery, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.; Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA., Najm I; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA., Punia V; Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. puniav@ccf.org.
Jazyk: angličtina
Zdroj: Neurological research and practice [Neurol Res Pract] 2024 Aug 01; Vol. 6 (1), pp. 39. Date of Electronic Publication: 2024 Aug 01.
DOI: 10.1186/s42466-024-00334-3
Abstrakt: Introduction: 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.
Methods and Analysis: 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 (≥ 50 years old) exhibiting elevated risk for common neurological disorders: stroke, epilepsy, Parkinson's Disease, or Alzheimer's disease and related dementias. Participants will be randomly assigned to intervention (n = 100) or control (n = 100) 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' 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.
Perspectives: 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.
Trial Registration: 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.
(© 2024. The Author(s).)
Databáze: MEDLINE
Externí odkaz: