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

NCT05103618 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 21D.632
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; Idiopathic Parkinson Disease

Keywords

Alternative Medicine; Complementary Medicine; Parkinson's disease; Neurodegenerative Diseases; Idiopathic Parkinson's disease; Central Nervous System Diseases; Movement Disorders; [F-18] Fluorodopa; Magnetic Resonance Spectroscopy PET; Positron Emission Tomography; Dopaminergic Function

Outcome Measures

Primary Outcomes (2)

• FDOPA PET

  The primary outcome measure will be the specific uptake values at 3 to 4 hours post administration, when the distribution of FDOPA has approached a transient, near equilibrium like state that reflects the ratio of k3/k4, which is related to binding potential. This allows for a quantitative assessment of dopamine activity.

  Subjects will receive FDOPA imaging at baseline

• FDOPA PET

  The primary outcome measure will be the specific uptake values at 3 to 4 hours post administration, when the distribution of FDOPA has approached a transient, near equilibrium like state that reflects the ratio of k3/k4, which is related to binding potential. This allows for a quantitative assessment of dopamine activity.

  Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes in Dopaminergic Function.]

Other Outcomes (12)

• The Speilberger State Trait Anxiety Inventory

  These will be obtained initially at baseline or the first imaging appointment

• The Speilberger State Trait Anxiety Inventory

  Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes

• The Profile of Moods Scale

  These will be obtained initially at baseline or the first imaging appointment

Study Arms (3)

Healthy Control Couple Pairs

ACTIVE COMPARATOR

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.

Behavioral: OM Meditation

Active Couple Pairs Parkinson's Group

ACTIVE COMPARATOR

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.

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

Waitlist Couple Pairs Parkinson's Group

OTHER

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

Drug: [F-18] Fluorodopa Positron Emission Tomography

Interventions

[F-18] Fluorodopa Positron Emission Tomography DRUG

Subjects will receive FDOPA imaging at baseline and 2-3 months after practicing the OM Meditation for evaluation of the dopamine function, \[F-18\] Fluorodopa (FDOPA), dose (5-10 mCi, ± 20%) will be injected intravenously into an antecubital vein. In accordance with the standard imaging protocol for FDOPA; subjects will be pre-medicated with 200 mg of carbidopa orally approximately one hour prior to injection.

Also known as: FDOPA PET/MRI

Active Couple Pairs Parkinson's Group; Waitlist Couple Pairs Parkinson's Group

OM Meditation BEHAVIORAL

Couple pairs will engage in OM Meditation together approximately 3-4 times a week approximately 2-3 months.

Active Couple Pairs Parkinson's Group; Healthy Control Couple Pairs

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No clinical diagnosis of PD
• Age 25 years old and older
• Physically independent, ambulatory
• 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.
• Clinical diagnosis of PD in female partner
• Age 30 years old and older
• Physically independent, ambulatory
• Hoehn and Yahr score of I-III inclusive.
• On stable antiparkinsonian medication for at least one month
• 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.
• No clinical diagnosis of PD
• Age 25 years old and older
• Physically independent, ambulatory
• 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.

You may not qualify if:

• Previous brain surgery.
• Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
• Wheelchair-bound or bed-ridden, non-ambulatory.
• Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
• Diagnosis of traumatic brain injury with significant impairment.
• 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.
• No metal in their body that would prevent MRI scanning (as determined by the PI).
• Subjects with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
• Subjects with current alcohol or drug abuse.
• Pregnant or lactating women.
• Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
• Pending surgery during the course of the study.
• History of thrombocytopenia or clotting disorders.
• Cancer patients receiving active chemotherapy.
• History of uncontrolled diabetes and/or thyroid conditions.

Sponsors & Collaborators

• Andrew Newberg: lead

Study Sites (1)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Central Nervous System Diseases; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Nervous System Diseases; Synucleinopathies

Study Officials

• Daniel A Monti, MD,MBA

  TJU, Integrative Medicine and Nutritional Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Department of Integrative Medicine and Nutritional Sciences; Professor, Department of Radiology

Model Details: This is an Open Label study. Subjects will be assigned a study number that will be used on the research files. Two group of couple pairs will be enrolled into this study: one group will be healthy couple pairs in which neither member has PD. The other couple pairs will include a female member with PD. For subjects who are enrolled in the meditation training programs couple pairs in which the female member has PD may be assigned to an active group or a waitlist control group.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 2, 2021
• Study Start: July 8, 2021
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Study scan report will be offered to the subject after subject completes study
• Access Criteria: Access only to authorized research staff and study participants

Locations

US (1)