ACTIVE_NOT_RECRUITING

Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

Conditions

Neurological Disorder Dementia Parkinson's disease Stroke Epilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-07-13

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05984056

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Vineet Punia, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: Vineet Punia MD

Vineet Punia, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-13

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-07-13

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

Dementia
Parkinson's disease
Stroke
Epilepsy

Additional Relevant MeSH Terms

Neurological Disorder