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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 60-90 days ( approximately 2-3 months) to access changes
Awards & highlights
FDOPAOM Trial 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.Check my eligibility
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.See study design
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.
FDOPAOM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
FDOPAOM Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
FDOPA PET
Other outcome measures
Marital Intimacy Questionnaire
Parkinson's Disease Questionnaire-39
The Beck Depression Inventory
+3 moreFDOPAOM 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.
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Who is running the clinical trial?
Andrew NewbergLead Sponsor
Daniel A Monti, MD,MBAStudy ChairTJU, Integrative Medicine and Nutritional Sciences
1 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for surgery during the study period.I am currently undergoing chemotherapy for cancer.I have been on stable medication for Parkinson's disease for at least a month.I am using or willing to use effective birth control during the study.My female partner has been diagnosed with Parkinson's disease.I have diabetes or thyroid conditions that are not well-managed.I cannot walk and use a wheelchair or stay in bed.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 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 not been diagnosed with Parkinson's disease.I have severe kidney disease with a GFR less than 30.My Parkinson's disease is in the early to mid-stage.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Couple Pairs Parkinson's Group
- Group 2: Active Couple Pairs Parkinson's Group
- Group 3: Healthy Control Couple Pairs
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Healthy Control Couple Pairs been sanctioned by the FDA?
"Considering the trial's Phase 2 status and the preliminary safety data that exists, our team has assigned Healthy Control Couple Pairs a score of 2 on a scale from 1 to 3."
Answered by AI
Is there still room for participants in this research endeavor?
"Clinicaltrials.gov attests that this medical experiment is not actively enrolling patients at present, despite having been initially listed on August 1st 2022 and updated most recently on July 11th 2022. Nevertheless, 484 other trials are currently recruiting participants."
Answered by AI
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