Meditation for Parkinson's Disease (FDOPAOM Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Andrew Newberg

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this research is to use 18 F Fluorodopa positron emission tomography (FDOPA PET) to measure dopamine function, and utilize magnetic resonance imaging (MRI) to measure inflammatory and oxidative stress markers in persons with Parkinson's disease. The overall goal of this study will be to further the understanding of the effects of a novel meditation technique called orgasmic meditation (OM) on these neurophysiological parameters.

Eligibility Criteria

This trial is for couples where one partner has Parkinson's Disease (PD) and the other doesn't. Eligible participants are over 25, can move around on their own, and women must not be pregnant and use birth control. People with previous brain surgery, cognitive issues, non-ambulatory status, certain brain abnormalities, significant psychiatric disorders or substance abuse aren't eligible.

Inclusion Criteria

I am 25 years old or older.

I am 30 years old or older.

I can walk and move around on my own.

I have not been diagnosed with Parkinson's disease.

My Parkinson's disease is in the early to mid-stage.

Exclusion Criteria

I am scheduled for surgery during the study period.

I am currently undergoing chemotherapy for cancer.

I have diabetes or thyroid conditions that are not well-managed.

I cannot walk and use a wheelchair or stay in bed.

I have a history of low platelet counts or clotting disorders.

I have a traumatic brain injury that significantly affects my daily life.

I don't have brain conditions that could affect scan readings.

I have had brain surgery before.

I don't have any health issues that could affect Parkinson's disease symptom evaluation or PET-MRI scans.

I have severe kidney disease with a GFR less than 30.

Treatment Details

The study measures dopamine function using FDOPA PET scans and checks for inflammation in the brain with MRI in people with PD. It aims to understand how a meditation technique called orgasmic meditation (OM) affects these neurophysiological parameters.

3Treatment groups

Experimental Treatment

Active Control

Group I: Waitlist Couple Pairs Parkinson's GroupExperimental Treatment1 Intervention

15 Couple pairs (30 subjects) in which one female member has a diagnosis of PD. The female subject will undergo the baseline scan. Both members of the couple will complete surveys The waitlist period in which the female member with PD will continue to receive standard of care for those 2-3 months; who then receive follow up scan. After the follow up scan, the waitlist group may be trained in the practice of OM for the next two months (but there will not be an additional FDOPA scan). Couple-pairs in the waitlist group will be asked to complete surveys at baseline and follow up scan and again after completing the OM Meditation practice. Couple pairs will engage in OM Meditation together approximately 3-4 times a week after the baseline and follow up scans for 2-3 months but female subjects with PD will not receive and additional post OM Meditation FDOPA scan

Group II: Active Couple Pairs Parkinson's GroupActive Control2 Interventions

15 Couple pairs (30 subjects) in which one female member has a diagnosis of PD. The female subject will undergo the baseline scan. Both members of the couple will complete surveys. The active group will receive training materials in the practice of OM which they will be asked to practice for the next 2-3 months The active couple-pair will begin the OM practice initially (in between the baseline and follow up). FDOPA scans will be conducted with female members with PD the couple pair at approximately 2-3 months.

Group III: Healthy Control Couple PairsActive Control1 Intervention

All healthy control subjects, 6 couple pairs (12 subjects) healthy controls in which neither member has Parkinson's Disease will receive a baseline and follow up FDOPA PET scan. All subjects will be asked to complete the surveys. The control group will receive training materials in the practice of OM which the couple will be asked to practice for the next 2-3 months. The couple-pair will begin the OM practice initially (in between the baseline and follow up scans. FDOPA scans and surveys will be conducted with both members of the couple pair at approximately 2-3 months.