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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special meditation technique, called orgasmic meditation (OM), might affect brain chemistry and inflammation in people with Parkinson's disease. Researchers will use advanced imaging, specifically [F-18] Fluorodopa Positron Emission Tomography (a type of brain scan), to measure dopamine activity and stress markers in the brain. Participants will be in couple pairs, with the woman having Parkinson's, and they will practice OM together. This study suits women diagnosed with Parkinson's who are physically active and on stable medication. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that meditation is generally safe for people with Parkinson's disease. One study focused on mindfulness meditation and found it safe for participants, with no major side effects reported. Participants received it well. Another study suggested some precautions, such as avoiding walking meditation to prevent falls in those with balance problems. Overall, these findings suggest meditation is a safe option for many individuals with Parkinson's.

FDOPA PET scans are a common imaging tool in medical research and carry low risk. Researchers use these scans to study brain function, and they have been widely used without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of OM Meditation for individuals with Parkinson's Disease (PD). Unlike standard treatments for PD, which often involve medications like Levodopa to manage symptoms, this approach focuses on a non-drug intervention that could enhance quality of life through mindfulness and stress reduction. Additionally, the use of [F-18] Fluorodopa Positron Emission Tomography (FDOPA PET) scans allows researchers to observe brain changes and neurotransmitter activity in response to meditation. This trial could provide insights into how meditation might complement existing therapies, potentially offering a holistic way to support those with PD.

What evidence suggests that this trial's treatments could be effective for Parkinson's disease?

Research has shown that meditation can positively affect Parkinson's disease (PD). One study found that practicing walking meditation at home reduced the severity of the disease in PD patients. Another study demonstrated that meditation, combined with yoga, lowered anxiety and depression in people with PD. Additionally, activities like structured dance and music therapy, which have calming effects similar to meditation, may help slow the progression of PD's movement-related symptoms. Since stress can exacerbate PD symptoms, mindfulness meditation might help by managing stress levels. This trial will explore the effects of OM Meditation on PD symptoms. Participants in the active couple pairs group will practice OM Meditation, while those in the waitlist couple pairs group will initially continue with standard care before potentially engaging in OM Meditation. These findings suggest that techniques like OM Meditation could ease symptoms for those with PD. ^{1 4 6 7 8}

Who Is on the Research Team?

Daniel A Monti, MD,MBA

Principal Investigator

TJU, Integrative Medicine and Nutritional Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11558214/

Impact of Dance or Music and Meditation on the ... This study aims to evaluate the effectiveness of dance or music and meditation on PD progression, cognitive functions, mood, behavior, and caregiver burden.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9862216/

A randomized clinical trial of mindfulness meditation versus ... A clinical trial of yoga involving 138 PD patients demonstrated its significant superior therapeutic effects on alleviating anxiety and ...

3. karger.com karger.com/pps/article/doi/10.1159/000543457/921833/Effects-of-Meditation-and-Yoga-on-Anxiety

Effects of Meditation and Yoga on Anxiety, Depression ... Home-based walking meditation decreases disease severity in Parkinson's disease: a randomized controlled trial . J Integr Complement Med.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2590112525000702

Impact of dance/music and meditation on the progression ... The results indicate that structured dance and music therapy may help alleviate the progression of motor symptoms in Parkinson's disease patients. The ...

5. nature.com nature.com/articles/s41531-020-00152-9

Stress and mindfulness in Parkinson's disease – a survey ... We conclude that PD patients experience greater levels of stress than controls, and that stress worsens both motor and non-motor symptoms.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4842053/

Mindfulness for Motor and Nonmotor Dysfunctions in ... Walking meditation was omitted for safety purposes given postural and gait instability issues in PD. The language and pace of instructions were also ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S197613171730511X

The Effects of Mindfulness Meditation-Based Complex ... The present study was to examine the effect of a meditation-based exercise program on the motor and non-motor symptoms of Parkinson's disease (PD).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02107638

Effect of Osteopathic Manipulative Medicine on Parkinson ... We are proposing a pilot study to investigate the impact of OMM on balance, motor function, and falling in PD patients. We are also going to screen for serum ...