When Cleveland Clinic’s Neurological Institute launched its first-of-kind Cleveland Clinic Brain Study early this year, the researchers hoped it would prompt funding for spinoff studies that leverage its massive longitudinal collection of data across scores of adults without known neurological disease. Just four to five months into the study, that has already happened: The state of Ohio has awarded the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University a $2 million grant to conduct a randomized, controlled trial to assess the impact of multidisciplinary lifestyle interventions for preventing or delaying neurological disorders.
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The new study — Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS) — will draw participants from the Cleveland Clinic Brain Study and will assess lifestyle interventions being evaluated in another ongoing Cleveland Clinic trial in adults with difficult-to-treat epilepsy.
In the epilepsy study, the lifestyle interventions — cognitive behavioral therapy, yoga and music therapy — are being tested for their effect on seizure control and epilepsy-associated comorbidities. In the MINDS Study, these same lifestyle interventions plus dietary education will be evaluated for potential effects on biomarkers of neurodegenerative disease in neurologically healthy adults who have early signs of brain pathology but no neurological disorder.
“We are excited to be able to align and leverage these various investigations in this way,” says Imad Najm, MD, Director of Cleveland Clinic’s Charles Shor Epilepsy Center, who serves as a principal investigator (PI) or co-PI on all three studies. “These studies represent the first steps toward the design of comprehensive protocols for the diagnosis of a ‘pre-disease state’ and the implementation of protocols for neurological disease prevention.
“This grant supporting the MINDS Study is an important early validation from a government agency of the value of the Cleveland Clinic Brain Study as a platform for broad research into neurological disease,” adds Cleveland Clinic epileptologist Vineet Punia, MD, MS, who serves as PI of the MINDS Study.
MINDS Study at a glance
The new study will recruit 200 participants from the longitudinal Cleveland Clinic Brain Study, which is enrolling thousands of adults aged 50 or older (or aged 20 or older if they have a first-degree relative with multiple sclerosis) with no known neurological disorder. As detailed in a prior Consult QD post, these volunteers undergo multimodal assessments at baseline and regular intervals thereafter for hypercharacterization of brain and body system changes — everything from cognition, brain structure and neurophysiology to voice, vision, and cardiovascular and digestive health. The suite of tests includes brain MRI, EEG, sleep studies, neuroperformance tests, neurological and neuropsychological exams, quality-of-life measures, blood tests (for genomic and proteomic characterization), stool tests (for microbiome assessment), electrocardiogram and echocardiogram.
Key objectives of the Cleveland Clinic Brain Study include early identification of individuals at risk for various neurological disorders — during the “silent” phase, prior to clinically recognizable disease onset — and identification of early biomarkers that can serve as predictors of neurological disease over time.
The 200 participants in the new MINDS Study will be drawn from Brain Study participants whose initial testing shows early signs of brain pathology that put them at risk of developing any of five neurological disorders: dementia, a movement disorder, epilepsy, multiple sclerosis or stroke. These individuals will be randomly assigned to one of two study groups:
- An intervention arm whose participants receive three months of weekly live virtual classes on each of four lifestyle interventions: yoga, music therapy and cognitive behavioral therapy for stress management, as well as dietary education centered on the MIND diet, which has been shown to slow cognitive decline.
- A control arm whose participants receive a monthly phone call from a research coordinator to check on their overall well-being.
All participants will undergo extensive examinations and biomarker testing at enrollment, at the end of the intervention phase (three months) and at study’s end (12 months).
The primary outcome measure will be reduction or normalization in any disease-specific biomarkers at the 12-month study endpoint. “We are relying on biomarkers rather than disease development because disease development is a slower process that typically takes several years,” Dr. Punia explains. “We hypothesize that participants randomized to these multidimensional lifestyle interventions will show slower progression toward the disease state, in terms of lower levels of known biomarkers of neurological disease. By comparing the two treatment groups, we also hope to identify any neurobiological measures that are impacted by these lifestyle interventions.”
Potential implications abound
The researchers hope their findings may spur further research for validation in a larger study cohort, with the potential for finer pinpointing of which combinations of biomarkers are most predictive of disease development. “For instance, this might ultimately lead to convenient ways to provide yearly cognition checkups for aging patients in the primary care setting, to pick up subtle signs of dementia,” Dr. Punia observes.
Similarly, results showing a positive impact of the lifestyle interventions could eventually result in evidence-informed lifestyle courses and coaches to promote neurological and general wellness. “These lifestyle interventions could be formalized into goals and interventions for integration into primary care and neurological care for older adults,” Dr. Punia notes. “There is considerable interest in nonpharmacologic interventions to help slow or prevent neurodegenerative disease and related disorders.”
Dr. Najm adds that compelling findings from this initial study could also be further tested and validated in a future larger sample of participants from the Cleveland Clinic Brain Study as its enrollment continues to grow over its planned duration of 20 years or more. “That is the beauty of our Brain Study initiative,” he says. “It will be an unprecedented opportunity for clinician-researchers and basic science researchers to explore various research questions around brain health without the burden of having to generate preliminary data. The Brain Study will yield a continuous and ever-growing supply of rich data for neurological research purposes. It is a research platform, not an end in itself. This large longitudinal investigation will mushroom into multiple studies that we believe will lead to early diagnosis and cure of — and perhaps ultimately the prevention of — neurological diseases.”