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

Vineet Punia MD

Status

Active, not recruiting

Conditions

Neurological Disorder

Treatments

Behavioral: Multidisciplinary lifestyle interventions

Study type

Interventional

Funder types

Other

Identifiers

NCT05984056

22-941

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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