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Neurological DisorderMINDSNCT05984056

Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

A study testing Multidisciplinary lifestyle interventions in people with Neurological Disorder, run by Vineet Punia MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Neurological Disorder
What is being tested?
Multidisciplinary lifestyle interventions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
13 Jul 2023to Jun 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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.
Read more

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
Read the detailed description

In this prospective, controlled, randomized study, investigators will enroll neurologically healthy but at-risk individuals (defined based on the pre-defined, disease-specific criteria described below in the "Eligibility" section) to assess the effectiveness of multidisciplinary lifestyle interventions [MLI, which includes the following: brain health training, yoga, music therapy, and Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS) diet education] on delaying, preventing, or reversing the progressive expression of known and novel neurological disorder biomarkers.

The study team will accomplish the abovementioned objectives by comparing 200 participants randomly assigned to the MLI arm (12 weekly instructor-led virtual group sessions followed by nine months of self-practice) or the control arm. All participants (including those enrolled in the control arm) will receive the MIND Study Activity Survey every two weeks during this first 12-week period.

Participants will undergo neuroimaging, neuropsychology, and neurophysiology testing and provide biosamples for genomic, proteomic, and metabolomic analysis along with various survey questionnaires at 3-time points: study enrollment, at the 12-week mark, and at the end of the study (12-month).

The primary outcome of the study is "pathology progression," which will be considered positive when the known biomarker used for initial participant selection increases over the study period. Rest will be considered as not showing "pathology progression." Various biomarkers collected using the abovementioned tests will be compared within and between the intervention and observation groups, and their correlation to pathology progression will be analyzed. This longitudinal, correlational testing will help this exploratory study reveal potential novel biomarkers of early neurological disorder and the ones that show the impact of MLI.

Being tested
Multidisciplinary lifestyle interventions
Keywords
Dementia, Parkinson's disease, Stroke, Epilepsy
Medical subject headings
Nervous System Diseases, Dementia, Parkinson Disease, Stroke, Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary lifestyle interventionsBehavioural

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

Study groups in NCT05984056
Study groupRoleWhat they receive
InterventionExperimentalMultidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.
Receives: Behavioral: Multidisciplinary lifestyle interventions
ControlNo interventionNo intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (6)

  1. Quality of Life in Neurological Disorders (Neuro QoL)

    Neuro-QOL uses a 5-point scale for scoring items, with questions ranging from least (1) to most (5) Neuro-QOL uses a T score with a mean of 50 and SD of 10 High scores indicate worse or undesirable, self-reported health.

    Measured: 12 months

  2. PHQ8 (Patient Health Questionnaire)

    It is an eight-item questionnaire used to screen for and assess the severity of depression. The PHQ-8 total score ranges from 0 to 24. A score of 0 to 4 indicates no depression, 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression and 20 or higher indicates severe depression. A score of 10 or greater is considered major depression, and 20 or more is severe major depression.

    Measured: 12 months

  3. Generalized Anxiety Disorder Questionnaire-7 (GAD-7)

    A screening instrument used to detect anxiety symptoms. The total score for the seven items in the GAD-7 ranges from 0 to 21. The scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day".

    The scores are interpreted as follows:

    0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15 or greater: Severe anxiety 6-10: Moderate 11-15: Moderately severe anxiety

    Scores above 10 are considered to be in the clinical range.

    Measured: 12 months

  4. General Self-Efficacy Scale (GSE)

    The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with difficult demands in life (coping skills). The minimum score for GSE is 10, and the maximum is 40.

    The higher the score, the greater the individual's generalized self-efficacy belief.

    Measured: 12 months

  5. Perceived Stress Scale (PSS-10)

    The Perceived Stress Scale (PSS) is a 10-item questionnaire that evaluates participants' self-reported amount of stress by assessing their thoughts and feelings in the previous month. Each question is scored from 0 (never) to 5 (very often), with a total possible score range of 0 to 40.

    Higher scores indicate a higher level of stress.

    Here are some cut-off scores for the PSS:

    0-13: low stress 14-26: moderate stress 27-40: high perceived stress 14 and 27: cut-off scores for moderate and high perceived stress, respectively The estimated minimal clinically important difference for the PSS-10 is 11 points

    Measured: 12 months

  6. Patient-Reported Outcomes Measurement Information System (PROMIS)

    PROMIS is a system of measures that evaluates and monitors adults' physical, mental, and social health.

    PROMIS scores range from 36.3 to 82.7, with higher scores indicating worse outcome.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start13 Jul 2023
  3. Primary completionJun 2036 (estimated)
  4. Study completionJun 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984056
Sponsor's protocol ID
22-941
Acronym
MINDS
Status last verified
Jul 2026
First submitted
2 Aug 2023
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30291317

  • 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.

    PubMed 26407649

  • 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.

    PubMed 26086182

  • 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.

    PubMed 34334393

  • 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.

    PubMed 29637549

  • 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.

    PubMed 29868647

  • 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.

    PubMed 34715355

  • 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.

    PubMed 25771249

  • 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.

    PubMed 27474376

  • 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.

    PubMed 28359749

  • 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.

    PubMed 39085927

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary lifestyle interventions in people with Neurological Disorder, run by Vineet Punia MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathology progression (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05984056, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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