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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
MINDS Trial Summary
This trial tests if lifestyle interventions can slow down or even reverse the expression of neurological diseases or their biomarkers. Participants will receive weekly, instructor-led virtual sessions for 12 weeks and be encouraged to practice what they learned for nine more months.
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.Check my eligibility
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.See study design
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.
MINDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathology progression
Secondary outcome measures
General Self-Efficacy Scale (GSE)
Generalized Anxiety Disorder Questionnaire-7 (GAD-7)
PHQ8 (Patient Health Questionnaire)
+3 moreMINDS 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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Who is running the clinical trial?
Vineet Punia MDLead Sponsor
Ohio Department of higher educationUNKNOWN
Vineet Punia, MDPrincipal InvestigatorThe Cleveland Clinic
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment currently available to participants for this research project?
"As per the information listed on clinicaltrials.gov, this examination is still seeking eligible participants. It was first published on July 13th 2023 and last updated later that month, August 2nd 2023."
Answered by AI
How many participants are the maximum that can join this research project?
"Yes, there is confirmation on clinicaltrials.gov that this medical study was first announced on July 13th 2023 and has been actively recruiting ever since. The trial requires 200 participants from a single location."
Answered by AI
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