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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
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 moreAwards & 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.
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.
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.
Find a Location
Who is running the clinical trial?
Vineet Punia MDLead Sponsor
Ohio Department of higher educationUNKNOWN
Vineet Punia, MDPrincipal InvestigatorThe Cleveland Clinic
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.