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Radiopharmaceutical

Meditation for Parkinson's Disease (FDOPAOM Trial)

Phase 2

Waitlist Available

Research Sponsored by Andrew Newberg

Eligibility Criteria Checklist

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

Must have

Age 25 years old and older

Age 30 years old and older

Must not have

Pending surgery during the course of the study

Cancer patients receiving active chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline at 60-90 days ( approximately 2-3 months) to access changes

Awards & highlights

No Placebo-Only Group

Summary

This trial will use PET and MRI to study how a meditation technique called orgasmic meditation affects dopamine function and markers of inflammation and oxidative stress in people with Parkinson's disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive imaging techniques like PET scans and MRIs along with meditation practice rather than medication or surgical interventions, side effects are minimal but may include discomfort from staying still during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 25 years old or older.

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I am 30 years old or older.

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I can walk and move around on my own.

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I have not been diagnosed with Parkinson's disease.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for surgery during the study period.

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I am currently undergoing chemotherapy for cancer.

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

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

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

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

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

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I have had brain surgery before.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline at 60-90 days ( approximately 2-3 months) to access changes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline at 60-90 days ( approximately 2-3 months) to access changes

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline at 60-90 days ( approximately 2-3 months) to access changes for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

FDOPA PET

Other study objectives

Marital Intimacy Questionnaire

Parkinson's Disease Questionnaire-39

The Beck Depression Inventory

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 15Eligibility criteria met