Meditation for Parkinson's Disease

(FDOPAOM Trial)

Overseen By Nancy A Wintering

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrew Newberg

Must be taking: Antiparkinsonian

Disqualifiers: Brain surgery, Cognitive impairment, Non-ambulatory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants with Parkinson's disease be on stable antiparkinsonian medication for at least one month, so you will not need to stop taking these medications.

What data supports the effectiveness of the treatment for Parkinson's Disease?

Research shows that mindfulness meditation can help improve depressive symptoms and emotional stability in Parkinson's patients. Additionally, mind-body exercises, which include meditation, have been found to enhance cognitive function and quality of life in people with Parkinson's. ^{1 2 3 4 5}

Is meditation for Parkinson's disease safe for humans?

The research articles provided do not contain specific safety data on meditation for Parkinson's disease or related treatments like [F-18] Fluorodopa Positron Emission Tomography and OM Meditation. They focus on imaging techniques and treatment compliance rather than safety outcomes. ^{6 7 8 9 10}

How does the treatment using [F-18] Fluorodopa PET and OM Meditation differ from other treatments for Parkinson's disease?

[F-18] Fluorodopa PET is unique because it uses a special imaging technique to assess the function of dopamine-producing neurons in the brain, which is crucial for understanding Parkinson's disease. This approach can help track disease progression and the effects of treatments, offering insights that standard therapies might not provide. OM Meditation, as a complementary therapy, may help address cognitive and emotional symptoms by promoting relaxation and mental well-being. ^{6 7 8 10 11}

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.

Research Team

Daniel A Monti, MD,MBA

Principal Investigator

TJU, Integrative Medicine and Nutritional Sciences

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

Control Group: 6 healthy, normal couple pairs

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.

Exclusion Criteria

Enrollment in active clinical trial/experimental therapy within the prior 30 days

I am scheduled for surgery during the study period.

I am currently undergoing chemotherapy for cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline FDOPA PET scan and surveys are conducted for all participants

1 week

1 visit (in-person)

Waitlist Period

Waitlist group continues standard care for 2-3 months before follow-up scan

8-12 weeks

1 visit (in-person) for follow-up scan

Active Meditation Practice

Active group practices OM meditation for 2-3 months with follow-up FDOPA PET scan

8-12 weeks

1 visit (in-person) for follow-up scan

Follow-up

Participants are monitored for changes in mood, intimacy, and sexual function

4 weeks

Treatment Details

Interventions

• [F-18] Fluorodopa Positron Emission Tomography
• OM Meditation

Trial Overview 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.

Participant Groups

Group I: Waitlist Couple Pairs Parkinson's Group Experimental Treatment 1 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 Group Active Control 2 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 Pairs Active Control 1 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.

Who Is Running the Clinical Trial?

Andrew Newberg

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

In a study involving 68 patients with mild-to-moderate Parkinson's disease, mindfulness meditation significantly improved depressive symptoms compared to stretching and resistance training, with a large effect size at week 8.

Mindfulness meditation also helped maintain emotional stability at week 20, while both interventions showed similar benefits on cognitive performance, suggesting mindfulness could be a valuable addition to rehabilitation for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of mindfulness meditation versus exercise in Parkinson's disease during social unrest. Kwok, JYY., Choi, EPH., Wong, JYH., et al.[2023]

In a study involving 25 participants (9 normal volunteers and 16 patients with Parkinson's disease), the researchers found that measuring striatal uptake rate constants (KiFD) provided better discrimination between groups than estimating dopa decarboxylase (DDC) activity, suggesting KiFD is a more effective marker for assessing dopaminergic function in Parkinson's disease.

Both KiFD and the estimated k3D correlated significantly with disease severity ratings, but KiFD was found to be superior for clinical and research applications, indicating it may be more useful for early diagnosis of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical significance of striatal DOPA decarboxylase activity in Parkinson's disease. Ishikawa, T., Dhawan, V., Chaly, T., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

A randomized clinical trial of mindfulness meditation versus exercise in Parkinson's disease during social unrest. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

A potential case of remission of Parkinson's disease. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness based intervention in Parkinson's disease leads to structural brain changes on MRI: a randomized controlled longitudinal trial. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Mind-Body Exercises for Non-motor Symptoms of Patients With Parkinson's Disease: A Systematic Review and Meta-Analysis. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Study of Mindfulness Training on the Self-Awareness of Motor Symptoms in Parkinson's Disease - A Randomized Controlled Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

A dual-tracer study of extrastriatal 6-[18F]fluoro-m-tyrosine and 6-[18F]-fluoro-L-dopa uptake in Parkinson's disease. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

6-18F-L-dopa imaging of the dopamine neostriatal system in normal and clinically normal MPTP-treated rhesus monkeys. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Hypertension increases cerebral 6-18F-fluorodopa-derived radioactivity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Treatment of Parkinson disease, time and dosage: "does simple dosage facilitate compliance and therapeutic goals?". [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical significance of striatal DOPA decarboxylase activity in Parkinson's disease. [2016]

11. United States pubmed.ncbi.nlm.nih.gov

Reproducibility and discriminating ability of fluorine-18-6-fluoro-L-Dopa PET in Parkinson's disease. [2016]