Multidisciplinary lifestyle interventions for at-risk individuals with neurological disorders
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS)
This study is testing if a combination of brain health training, yoga, music therapy, and diet education can help people who are at risk of developing neurological disorders stay healthy and prevent disease progression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05984056 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of multidisciplinary lifestyle interventions (MLI) in neurologically healthy individuals who are at risk of developing neurological disorders. Participants will be randomly assigned to either an intervention group, receiving weekly virtual sessions on brain health training, yoga, music therapy, and diet education, or a control group. The study will assess changes in known and novel biomarkers of neurological disorders through neuroimaging, neuropsychological testing, and biosample analysis over a 12-month period. The primary goal is to determine if these interventions can slow down or reverse the progression of neurological disease markers.
Who should consider this trial
Good fit: Ideal candidates are neurologically healthy individuals aged 50 and older who show early signs of being at risk for conditions like dementia, Parkinson's disease, stroke, or epilepsy.
Not a fit: Patients with established neurological diseases or those not enrolled in the Cleveland Clinic Brain Study may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological approach to delay or prevent the onset of neurological disorders in at-risk individuals.
How similar studies have performed: Other studies have shown promise in using lifestyle interventions for neurological health, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Vineet Punia, MD — The Cleveland Clinic
- Study coordinator: Suman Kundu, MBA
- Email: kundus@ccf.org
- Phone: 216 554 7036
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.