MINDS: Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase

Sponsor

Vineet Punia MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05984056

Collaborator

Ohio Department of higher education (Other)

200

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

18.8

Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or Disease	Intervention/Treatment	Phase
Neurological Disorder	Behavioral: Multidisciplinary lifestyle interventions	N/A

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 in the "Eligibility" section) to assess the effectiveness of multidisciplinary lifestyle interventions (MLI, which include brain health training, yoga, music therapy, and 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.	Behavioral: Multidisciplinary lifestyle interventions Multidisciplinary lifestyle interventions (Brain health training, yoga, music therapy and CC-MIND diet education)
No Intervention: Control No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.

Arm

Intervention/Treatment

Experimental: Intervention

Multidisciplinary lifestyle interventions will be provided weekly for 12 weeks after enrollment.

Behavioral: Multidisciplinary lifestyle interventions

Multidisciplinary lifestyle interventions (Brain health training, yoga, music therapy and CC-MIND diet education)

No Intervention: Control

No intervention. Periodic check-ups will be performed during the first 12 weeks, followed by monthly check-ins like the intervention arm.

Outcome Measures

Primary Outcome Measures

Pathology progression [12 months]
At the time of study completion, a participant will be considered to show "Pathology progression" if they fulfill either of the two conditions: Clinically diagnosed with any of the above five conditions Show the following changes compared to the baseline: Stroke: Asymptomatic cortical infarct or further increase in white matter disease MRI changes Epilepsy: Increase in burden (per hour) of Spikes/Sharp Waves/Polyspikes or electrographic seizure on EEG Movement Disorder: >4 points increase on modified Unified Parkinson's Disease Rating Scale (UPDRS) administered remotely Dementia: Increase in number of domain testing ≤ 1.5 SD or drop in scores < 2SD Multiple Sclerosis (MS): Increase in the number of MRI lesions or volume of existing lesions

Secondary Outcome Measures

Quality of Life in Neurological Disorders (Neuro QoL) [12 months]
Neuro-QOL uses a 5-point scale for scoring items, with questions ranging from least (1) to most (5) Neuro-QOL uses a T score with a mean of 50 and SD of 10 High scores indicate worse or undesirable, self-reported health.
PHQ8 (Patient Health Questionnaire) [12 months]
It is an eight-item questionnaire used to screen for and assess the severity of depression. The PHQ-8 total score ranges from 0 to 24. A score of 0 to 4 indicates no depression, 5 to 9 indicates mild depression, 10 to 14 indicates moderate depression, 15 to 19 indicates moderately severe depression and 20 or higher indicates severe depression. A score of 10 or greater is considered major depression, and 20 or more is severe major depression.
Generalized Anxiety Disorder Questionnaire-7 (GAD-7) [12 months]
A screening instrument used to detect anxiety symptoms. The total score for the seven items in the GAD-7 ranges from 0 to 21. The scores are calculated by assigning scores of 0, 1, 2, and 3 to the response categories of "not at all," "several days," "more than half the days," and "nearly every day". The scores are interpreted as follows: 0-4: Minimal anxiety 5-9: Mild anxiety 10-14: Moderate anxiety 15 or greater: Severe anxiety 6-10: Moderate 11-15: Moderately severe anxiety Scores above 10 are considered to be in the clinical range.
General Self-Efficacy Scale (GSE) [12 months]
The GSE is a 10-item psychometric scale that assesses optimistic self-beliefs to cope with difficult demands in life (coping skills). The minimum score for GSE is 10, and the maximum is 40. The higher the score, the greater the individual's generalized self-efficacy belief.
International Physical Activity Questionnaire (IPAQ) [12 months]
IPAQ is a well-developed and widely-used instrument to measure physical activity in adults. The IPAQ scoring protocol assigns the following MET (minutes a week) values to walking, moderate, and vigorous-intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively. To get a continuous variable score from the IPAQ, you can consider walking to be 3.3 METS, moderate physical activity to be 4 METS, and vigorous physical activity to be 8 METS. Overall score: Excellent test-retest reliability (ICC = 0.81) Physical activity: Excellent test-retest reliability (ICC = 0.84-1.00) Sitting: Adequate test-retest reliability (ICC = 0.70)
Perceived Stress Scale (PSS-10) [12 months]
The Perceived Stress Scale (PSS) is a 10-item questionnaire that evaluates participants' self-reported amount of stress by assessing their thoughts and feelings in the previous month. Each question is scored from 0 (never) to 5 (very often), with a total possible score range of 0 to 40. Higher scores indicate a higher level of stress. Here are some cut-off scores for the PSS: 0-13: low stress 14-26: moderate stress 27-40: high perceived stress 14 and 27: cut-off scores for moderate and high perceived stress, respectively The estimated minimal clinically important difference for the PSS-10 is 11 points
Pittsburgh Sleep Quality Index (PSQI) [12 months]
PSQI is a questionnaire that assesses sleep quality and disturbances and has a global score that ranges from 0 to 21 points. The minimum score is 0, considered better, and the maximum score is 3, considered worse. The global score is calculated by adding up the average scores of seven factors. Higher scores indicate worse sleep quality. The developers of the PSQI suggest a cut-off score of 5 for the global scale, as it correctly identified 88.5% of the patient group in their validation study.
Patient-Reported Outcomes Measurement Information System (PROMIS) [12 months]
PROMIS is a system of measures that evaluates and monitors adults' physical, mental, and social health. PROMIS scores range from 36.3 to 82.7, with higher scores indicating worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants must be enrolled in Cleveland Clinic Brain Study (CCBS). CCBS is a prospective non-interventional study platform for the hypercharacterization 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 (and first-degree relatives older than 20 years of patients with multiple sclerosis, a disease that affects younger adults). 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 five 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
Multiple Sclerosis (MS): ≥3 MRI lesions ≥2 mm in diameter located in the juxtacortical, pericallosal, periventricular, or infratentorial white matter

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