Status:
ACTIVE_NOT_RECRUITING
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase
Lead Sponsor:
Vineet Punia MD
Collaborating Sponsors:
Ohio Department of higher education
Conditions:
Neurological Disorder
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05984056
Start Date
July 13 2023
End Date
June 1 2026
Last Update
July 8 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195