What is the mechanism of action of this treatment?

Common treatments for neurological disorders often include behavioral modification and education, which aim to improve patients' quality of life by addressing both motor and non-motor symptoms. Behavioral modification, such as physical exercise, can enhance motor function, reduce symptoms like tremors, and improve overall mobility. Education empowers patients with knowledge about their condition, enabling them to manage symptoms more effectively and adhere to treatment plans. These approaches are crucial as they not only target the physical aspects of neurological disorders but also support mental well-being, leading to a more holistic management of the disease.

What side effects are associated with this type of intervention?

Common treatments for neurological disorders that involve behavioral modification and education include lifestyle interventions, cognitive-behavioral therapy (CBT), and various forms of counseling. These treatments generally have a low risk of side effects compared to pharmacological interventions. However, some individuals may experience increased anxiety or emotional distress during the initial stages of therapy. Additionally, adherence to lifestyle changes can sometimes be challenging, leading to frustration or decreased motivation. Overall, these interventions are considered safe and beneficial for managing symptoms and improving quality of life.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of neurological disorders. For Huntington's disease, tetrabenazine and deutetrabenazine are used to manage chorea. Parkinson's disease treatments include levodopa, dopamine agonists, and MAO B inhibitors. Multiple sclerosis management involves drugs like dimethyl fumarate (BG-12) and glatiramer acetate, which reduce relapse rates and brain lesions. While these treatments are pharmacological, the Multidisciplinary Lifestyle Interventions trial focuses on behavioral modification and education, which are complementary approaches aimed at slowing or reversing neurological disorder progression.

What other types of research exist?

Promising novel alternatives to Multidisciplinary Lifestyle Interventions for neurological disorders in 2024 include: 1) Mind-Body Therapies such as mindfulness-based stress reduction and yoga, which have shown efficacy in managing symptoms and improving quality of life. 2) Advanced Physiotherapy techniques, including virtual reality-based rehabilitation and robotic-assisted therapy, which offer enhanced motor function recovery. 3) Neurofeedback and Brain-Computer Interface (BCI) technologies, which provide real-time feedback and control to improve cognitive and motor functions. 4) Integrative therapies like acupuncture and reflexology, which have been supported by systematic reviews for their effectiveness in symptom management. These alternatives can be considered in consultation with healthcare providers to tailor the best approach for individual patient needs.

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Behavioral Intervention

Lifestyle Interventions for Neurological Disorders (MINDS Trial)

N/A

Recruiting

Led By Vineet Punia, MD

Research Sponsored by Vineet Punia MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a mix of healthy activities and education can help people at risk of neurological disorders. Participants will do brain exercises, yoga, music therapy, and follow a healthy diet. The goal is to see if these activities can keep their brains healthier and delay or prevent neurological issues.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves lifestyle interventions rather than medication, side effects may include discomfort from new activities or dietary changes but no significant medical side effects are expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathology progression

Secondary study objectives

General Self-Efficacy Scale (GSE)

Generalized Anxiety Disorder Questionnaire-7 (GAD-7)

PHQ8 (Patient Health Questionnaire)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for neurological disorders often include behavioral modification and education, which aim to improve patients' quality of life by addressing both motor and non-motor symptoms. Behavioral modification, such as physical exercise, can enhance motor function, reduce symptoms like tremors, and improve overall mobility. Education empowers patients with knowledge about their condition, enabling them to manage symptoms more effectively and adhere to treatment plans. These approaches are crucial as they not only target the physical aspects of neurological disorders but also support mental well-being, leading to a more holistic management of the disease.

The psychotherapies in the context of new developments in the neurosciences and biological psychiatry.Treatment approaches for pusher behaviour: a scoping review.Evidence to support treatment options for children with swallowing and feeding disorders: A systematic review.