Evidence map›Paper›PMID 39085927›Full record

ArticleNeurological research and practice2024

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

Sara Taylor, Seerat Sachdeva, Sandra Darling, Kayela Arrotta, Lisa Gallagher, Alexis Supan, Gabrielle Shipta, Jim Perko, Judi Bar, Joe James and 20 more

Registry-linked trialAbstract read
In one paragraph

Article in Neurological research and practice, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05984056 (Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05984056 naactive not recruitingnot on this map

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

TypeinterventionalSponsorVineet Punia MDRan2023 to 2036Enrolled200ConditionsNeurological DisorderArmsMultidisciplinary lifestyle interventions
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Sara TaylorEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Seerat SachdevaDr. Sampurnanand Medical College, Jodhpur, Rajasthan, India.
Sandra DarlingPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Kayela ArrottaEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Lisa GallagherPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Alexis SupanPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Gabrielle ShiptaPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Jim PerkoPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Judi BarPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
Joe JamesEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Iris PetschekEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Anthony LioiEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Suman KunduEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Lisa EllisonEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Lynn M BekrisLerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.
Belinda WillardLerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.
Naseer SangwanLerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.
Ignacio MataLerner Research Institute, Genomic Medicine Institute, Cleveland Clinic, Cleveland, OH, USA.
Hubert FernandezCenter for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Irene KatzanCerebrovascular Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Devon ConwayMellen Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Jagan PillaiNeurological Institute, Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH, USA.
James LeverenzNeurological Institute, Cleveland Clinic Lou Ruvo Center for Brain Health, Cleveland Clinic, Cleveland, OH, USA.
Robyn M BuschEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Darlene FlodenCenter for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Robert SaperPrimary Care Institute, Wellness and Preventive Medicine, Cleveland Clinic, Cleveland, OH, USA.
John BarnardDepartment of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.
Andre MachadoCenter for Neurological Restoration, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Imad NajmEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Vineet PuniaEpilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. puniav@ccf.org.ORCID http://orcid.org/0000-0002-0552-6736

Funding

Ohio Department of Higher Education ODHE2212PV
6 · The paper itself

Abstract

introductionGiven 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 registrationThe 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.

Indexed as

Alzheimer’s diseaseBiomarkersEpilepsyLifestyle interventionsParkinson’s DiseaseRandomized controlled trialStroke

Identifiers

PMID39085927
PMCPMC11293137

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.