Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA (FDOPAOM)

Andrew Newberg

Status and phase: Not yet enrolling; Phase 2

Conditions: Idiopathic Parkinson Disease; Parkinson Disease

Treatments: Behavioral: OM Meditation; Drug: [F-18] Fluorodopa Positron Emission Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT05103618

21D.632

Details and patient eligibility

About

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.

Full description

The overall goal of this study is to further the understanding of the physiological and psychological effects and dopaminergic function of OM in couple pairs in a control group and in couples in which one member has Parkinson's disease (PD). This study will utilize F-18 Fluorodopa (FDOPA) positron emission tomography (PET) imaging which utilizes an experimental radioactive tracer called FDOPA which helps to evaluate the activity in the dopamine neurons in the brain. A secondary goal of this study is to determine whether undergoing OM meditation alters body or brain physiology, and to measure whether there is an effect on intimacy and sexual dysfunction in women with PD.

This study is designed to understand the changes that occurs when subjects undergo intense meditation or meditation induced by sensory stimulation and structured touch. This study is designed to allow researchers to understand the changes in couple-pairs that occur when subjects undergo a shared meditation practice. Since meditation practices are widely used by individuals, the Investigators hope that a better understanding of the effects of meditation practices will provide information regarding potential clinical uses.

80 subjects will be enrolled (6 healthy couple pairs) and 30 couple pairs in which one female member has PD. The Investigators will also for a 10% attrition to enroll a total of 72 subjects.

For evaluation of the dopamine function, [F-18] Fluorodopa (FDOPA), dose (5-10 millicurie (mCi), ± 20%) will be injected intravenously into an antecubital vein. Subjects will be premedicated with 200 mg of carbidopa orally approximately one hour prior to injection.

FDOPA has been available for over 30 years but has not been previously approved for commercial use by the FDA. The Investigators will be obtaining the FDOPA from the University of Pennsylvania cyclotron that has produced FDOPA for many Investigational New Drug applications (INDs) It will also be beneficial to assess whether there are specific changes in levels of different molecules that are related to energy consumption and oxidative stress. Proton MR spectroscopy (1H-MRS) has been previously performed in Parkinson's disease (PD) and parkinsonian syndromes to evaluate in vivo concentrations of basal ganglia and cerebral cortex metabolites such as N-acetylaspartate (NAA), choline (Cho), and creatine (Cr).

Enrollment: 80 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:(Control Group: 6 healthy, normal couple pairs)

1. No clinical diagnosis of PD
2. Age 25 years old and older
3. Physically independent, ambulatory
4. Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.

Inclusion Criteria for Female Partner in Couple Pairs in Parkinson's Group who has Parkinson's Disease

1. Clinical diagnosis of PD in female partner
2. Age 30 years old and older
3. Physically independent, ambulatory
4. Hoehn and Yahr score of I-III inclusive.
5. On stable antiparkinsonian medication for at least one month
6. Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.

Inclusion Criteria for Second Partner with No PD in Couple Pairs in Parkinson's Group

1. No clinical diagnosis of PD
2. Age 25 years old and older
3. Physically independent, ambulatory
4. Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.

Exclusion Criteria: (In Control Couple Pairs and in Couple Pairs Group in which the Female member has PD)

1. Previous brain surgery.
2. Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
3. Wheelchair-bound or bed-ridden, non-ambulatory.
4. Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
5. Diagnosis of traumatic brain injury with significant impairment.
6. Any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the PET-MRI imaging.
7. No metal in their body that would prevent MRI scanning (as determined by the PI).
8. Subjects with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
9. Subjects with current alcohol or drug abuse.
10. Pregnant or lactating women.
11. Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
12. Pending surgery during the course of the study.
13. History of thrombocytopenia or clotting disorders.
14. Cancer patients receiving active chemotherapy.
15. History of uncontrolled diabetes and/or thyroid conditions.
16. History of severe kidney disease (if a subject reports this problem, a serum creatinine will be checked to assess glomerular filtration rate (GFR) and if it is less than 30, they will be excluded).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Healthy Control Couple Pairs

Active Comparator group

Description:

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.

Treatment:

Behavioral: OM Meditation

Active Couple Pairs Parkinson's Group

Active Comparator group

Description:

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.

Treatment:

Drug: [F-18] Fluorodopa Positron Emission Tomography

Behavioral: OM Meditation

Waitlist Couple Pairs Parkinson's Group

Other group

Description:

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

Treatment:

Drug: [F-18] Fluorodopa Positron Emission Tomography