Lifestyle Interventions for Neurological Disorders

(MINDS Trial)

Overseen By Suman Kundu, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vineet Punia MD

Disqualifiers: Chronic illness, Intensive treatment, Pregnancy, Hearing loss, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how lifestyle changes, specifically through Multidisciplinary Lifestyle Interventions (MLI), can prevent or slow neurological issues in healthy individuals at risk. Participants will either join weekly virtual sessions for 12 weeks or be part of an observation group for comparison. The goal is to determine if these lifestyle interventions can delay the onset of conditions like stroke, epilepsy, movement disorders, or dementia. The trial suits those 50 and older who are part of the Cleveland Clinic Brain Study and show early signs of risk for these conditions but lack a diagnosed neurological disease. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new preventive strategies for neurological health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these lifestyle interventions are safe?

Research has shown that lifestyle changes involving exercise, diet, and stress management are generally safe and well-tolerated. These changes aim to support brain health and lower the risk of brain-related disorders.

Studies have found that people usually experience few, if any, negative effects from these lifestyle changes. Many even report feeling better overall. Since this trial focuses on lifestyle changes instead of medication, safety concerns are fewer. Participants are encouraged to make gradual, manageable changes to their daily routines, which helps prevent sudden or negative reactions.

Overall, evidence suggests that these lifestyle changes offer a safe way to potentially improve brain health and reduce the risk of future brain issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle interventions for neurological disorders because they take a holistic approach, combining multiple strategies like diet, exercise, and stress management. Unlike traditional treatments that often rely on medication, these interventions empower patients to actively participate in their own care, potentially leading to long-term health improvements and fewer side effects. Additionally, these interventions could address multiple aspects of neurological health simultaneously, offering a more comprehensive solution than focusing on symptom management alone.

What evidence suggests that these lifestyle interventions could be effective for neurological disorders?

This trial will compare Multidisciplinary Lifestyle Interventions with a control group receiving no intervention. Studies have shown that lifestyle changes across multiple areas can reduce the risk and slow the progression of brain disorders. This approach includes strategies such as dietary changes, exercise, and stress management. New evidence suggests that these lifestyle changes might improve brain health by addressing several factors simultaneously. Although more research is needed to confirm these benefits, early findings are promising. These changes aim to maintain brain function and possibly delay the onset of neurological problems. ^{1 2 3 5 6}

Who Is on the Research Team?

Vineet Punia, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for neurologically healthy individuals over 50, or relatives over 20 of MS patients, who are at risk of neurological disorders. They must be part of the Cleveland Clinic Brain Study and show early signs like smell loss, MRI changes, EEG abnormalities, memory issues or multiple brain lesions.

Inclusion Criteria

I am willing to undergo regular and detailed health checks including blood tests and scans.

I am at risk for stroke, epilepsy, movement disorder, or dementia but do not have a neurological disease.

Participants must be enrolled in Cleveland Clinic Brain Study (CCBS)

Exclusion Criteria

I have significant hearing loss.

Participants who are actively engaged in 2 or more of the study interventions

I am not undergoing any intense treatments for a serious illness that would affect my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive weekly, instructor-led intervention sessions (virtual group sessions) for 12 weeks

12 weeks

12 virtual group sessions

Self-practice

Participants practice learned interventions on their own for nine months

9 months

Monthly check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3 visits (in-person) at enrollment, 12 weeks, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Multidisciplinary Lifestyle Interventions

Trial Overview The study tests if lifestyle interventions can slow down or reverse neurological disorder symptoms. Participants will either receive weekly virtual sessions on lifestyle changes for three months followed by self-practice or they'll be observed without intervention.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Vineet Punia MD

Lead Sponsor

Trials

1

Recruited

200+

Ohio Department of higher education

Collaborator

Trials

1

Recruited

200+

Published Research Related to This Trial

Type 2 diabetes affects a significant portion of the American population, with lifestyle interventions being crucial for both initial treatment and ongoing management.

Effective management of type 2 diabetes includes a combination of healthy eating, physical activity, medication, and patient education to help control glucose, lipid levels, and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle intervention: nutrition therapy and physical activity. Evert, AB., Riddell, MC.[2014]

A multidisciplinary lifestyle enhancement treatment (MULTI) significantly improved physical activity, cardiometabolic risk factors, and psychosocial functioning in inpatients with severe mental illness (SMI) after 18 months, compared to standard treatment (TAU).

The implementation of MULTI faced challenges due to organizational factors, but was supported by positive attitudes from both healthcare professionals and patients, highlighting the importance of engagement in lifestyle changes for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Thinking inside the box: improving the lifestyle of inpatients with severe mental illness]. Deenik, J., Tenback, DE., Tak, ECPM., et al.[2021]

A 24-week lifestyle intervention, including exercise training and dietary changes, significantly improved physical activity and reduced salt intake in patients with noncardioembolic mild ischemic stroke, leading to better vascular risk factors like lower blood pressure and higher HDL cholesterol levels.

After nearly 3 years of follow-up, the lifestyle intervention group had significantly fewer new vascular events compared to the control group, indicating that lifestyle changes can effectively reduce the risk of future strokes and other vascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secondary prevention of new vascular events with lifestyle intervention in patients with noncardioembolic mild ischemic stroke: a single-center randomized controlled trial. Kono, Y., Yamada, S., Yamaguchi, J., et al.[2022]

The CURIAMO project involves a multidisciplinary lifestyle intervention for obesity and Type 2 diabetes, engaging around 1000 adults over a 3-year period, with a focus on achieving significant weight loss and increased physical activity.

The intervention aims for at least 70% of participants to lose 7% of their body weight and increase their physical activity by 10 MET/h-1·week-1 after one year, indicating a strong potential for long-term health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative model for changing the lifestyles of persons with obesity and/or Type 2 diabetes mellitus. De Feo, P., Fatone, C., Burani, P., et al.[2021]

The MULTI_sh lifestyle intervention did not lead to significant health improvements for people with severe mental illness living in sheltered housing, as shown in a study involving 74 participants over 12 months.

Implementation of MULTI_sh faced challenges due to organizational factors like staff shortages and complexity, indicating that successful lifestyle interventions require better support and strategies at the organizational level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the implementation of a multidisciplinary lifestyle intervention for people with severe mental illness in sheltered housing: effectiveness-implementation hybrid randomised controlled trial. Smit, MMC., Waal, E., Tenback, DE., et al.[2022]

A scoping review of 2555 articles identified only 13 nutrition education programs for adults with neurological diseases, indicating a significant gap in available resources for conditions like dementia, multiple sclerosis, and stroke.

Most programs lacked adherence to best practice principles in nutrition education, such as structured delivery and evaluation methods, highlighting the need for more effective and evidence-based programs to support dietary adherence in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education Programs for Adults with Neurological Diseases Are Lacking: A Scoping Review. Russell, RD., Black, LJ., Begley, A.[2022]

Recurrent strokes account for 23% of nearly 800,000 annual strokes, leading to higher risks of disability and mortality, highlighting the critical need for effective secondary stroke prevention strategies.

Modifiable risk factors such as diet, physical activity, smoking cessation, and alcohol consumption can significantly reduce stroke risk, and while lifestyle changes can be challenging for stroke survivors, targeted interventions and support can facilitate these modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Modification for Secondary Stroke Prevention. Bailey, RR.[2023]

Plant-based, low-fat, high-fiber diets rich in antioxidants may help reduce the impact of common neurological disorders like Alzheimer's and Parkinson's disease by addressing underlying issues such as oxidative stress and neuroinflammation.

The ketogenic diet is particularly effective for treating refractory epilepsy, highlighting how specific dietary interventions can target the metabolic disruptions associated with various neurological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Insights in Neurological Diseases. Ramírez-Salazar, SA., Herren, C., McCartney, J., et al.[2021]

Following a confirmed diagnosis, it is important to recommend lifestyle adjustments to improve health outcomes.

In specific clinical situations, medical therapy may also be necessary to effectively manage the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting hypertension under control in the youngest of patients. Smith, DK., McMullan, SM., Martin, MJ.[2021]

This review aims to identify and analyze various dietary education programs for adults with neurological diseases, which affect up to 1 billion people, including conditions like Alzheimer's and Parkinson's disease.

The review will evaluate program characteristics such as duration, session length, and behavior change techniques, providing insights into effective dietary interventions recommended by the World Health Organization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary education programs for adults with neurological diseases: a scoping review protocol. Russell, RD., Black, LJ., Begley, A.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39085927

a multi-omics randomized controlled trial protocol - PubMed Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11293137/

a multi-omics randomized controlled trial protocol - PMC Emerging evidence suggests that multidisciplinary lifestyle interventions (MLI) may mitigate the risk and progression of neurological disorders.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05984056

Multidisciplinary Lifestyle Interventions for Neurological ... This clinical trial aims to test the impact of multidisciplinary lifestyle interventions (MLI) in neurologically healthy but at-risk individuals.

4. trial.medpath.com trial.medpath.com/clinical-trial/f4bc8a7d10300cb2/nct05984056-multidisciplinary-lifestyle-interventions-neurological-disorders

Multidisciplinary Lifestyle Interventions for Neurological ... This clinical trial aims to test the impact of multidisciplinary lifestyle interventions (MLI) in neurologically healthy but at-risk individuals.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05984056/multidisciplinary-lifestyle-interventions-for-neurological-disorders-during-the-silent-phase

Multidisciplinary Lifestyle Interventions for Neurological ... This clinical trial aims to test the impact of multidisciplinary lifestyle interventions (MLI) in neurologically healthy but at-risk ...

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000206048

Multidisciplinary Lifestyle Interventions for Neurological ... The MINDS study explores MLI in 'at-risk' older adults, providing data for future proof-of-concept studies on pre-clinical and MLI responsiveness biomarkers.