Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

Description

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

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Study Overview

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Study Details

Study overview

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

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

Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

Condition
Neurological Disorder
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.
  • 2. 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
  • 1. Participants who are actively (at the time of enrollment) engaged in 2 or more of the study interventions.
  • 2. 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.
  • 3. 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.
  • 4. Participants who are currently pregnant or less than six weeks postpartum
  • 5. Participants with significant hearing loss
  • 6. Participants with severe impairment of vision/ blindness
  • 7. Participants who require a legally authorized representative (LAR) or lack the capacity to consent for themselves

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Vineet Punia MD,

Vineet Punia, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-06