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

Primary Purpose

Parkinson Disease, Idiopathic Parkinson Disease

Status

Not yet recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

[F-18] Fluorodopa Positron Emission Tomography

OM Meditation

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring 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

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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.

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

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.

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

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.

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

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.
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).

Sites / Locations

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Other

Arm Label

Healthy Control Couple Pairs

Active Couple Pairs Parkinson's Group

Waitlist Couple Pairs Parkinson's Group

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

FDOPA PET

Secondary Outcome Measures

Full Information

NCT ID

NCT05103618

First Posted

October 21, 2021

Last Updated

July 7, 2023

Sponsor

Andrew Newberg

1. Study Identification

Unique Protocol Identification Number

NCT05103618

Brief Title

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

Acronym

FDOPAOM

Official Title

Evaluating the Physiological and Psychological Effects of a Novel Meditation Technique on Cerebral Activity Measured With Functional Magnetic Resonance Imaging(fMRI) and F-18 Fluorodopa PET Imaging

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2023 (Anticipated)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew Newberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control Couple Pairs

Arm Type

Active Comparator

Arm Description

Arm Title

Active Couple Pairs Parkinson's Group

Arm Type

Active Comparator

Arm Description

Arm Title

Waitlist Couple Pairs Parkinson's Group

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

[F-18] Fluorodopa Positron Emission Tomography

Other Intervention Name(s)

FDOPA PET/MRI

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

OM Meditation

Intervention Description

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

Primary Outcome Measure Information:

Title

FDOPA PET

Description

Time Frame

Subjects will receive FDOPA imaging at baseline

Title

FDOPA PET

Description

Time Frame

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

Other Pre-specified Outcome Measures:

Title

The Speilberger State Trait Anxiety Inventory

Description

The Spielberger State Trait Anxiety Inventory (STAI-Y) Contains a total of 40 questions, The range of possible scores for the STAI-Y form varies from a minimum score of 20 to a maximum score of 80 on both the STAI-Trait and STAI-State subscales. STAI scores are commonly classified as no or low anxiety score range (20-37), moderate anxiety score range (38-44), and high anxiety score range of (45-80). A higher score indicates more anxiety.half of which relate to the way subjects are feeling at the moment and half of which ask them to describe how they usually feel.

Time Frame

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

Title

The Speilberger State Trait Anxiety Inventory

Description

Time Frame

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

Title

The Profile of Moods Scale

Description

Profile of Mood States is a standardized self-report inventory will be administered to evaluate changes in mood, current state or traits. is a psychological rating scale used to assess transient, distinct mood states. The questionnaire contains 65 words that are rated on a scale of zero for not at all to 4 for extremely. There are 5 mood subscales: tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. A higher score for the total mood indicates a greater degree of mood disturbance.A Total Mood Disturbance (TMD) can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion and then subtracting the vigour score. This will give a value between -24 and 177, with lower scores indicative of people with more stable mood profiles.

Time Frame

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

Title

The Profile of Moods Scale

Description

Time Frame

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

Title

The Beck Depression Inventory

Description

Beck Depression Inventory (Beck 1972) is a 21 question self report inventory to access depression and changes in mood. The highest possible total for the whole test would be 63; the lowest possible score for the test would be zero. A higher score indicates worse symptoms of depression and mood.

Time Frame

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

Title

The Beck Depression Inventory

Description

Beck Depression Inventory Beck 1972) is a 21 question self report inventory to access depression and changes in mood. The highest possible total for the whole test would be 63; the lowest possible score for the test would be zero. A higher score indicates worse symptoms of depression and mood.

Time Frame

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

Title

Marital Intimacy Questionnaire

Description

The Marital Intimacy Questionnaire (MIQ) is a theory-based self-report questionnaire assessing 5 components of marital intimacy. Construct validity was established by examining the correlations of the MIQ with measures of marital satisfaction, perceived global intimacy, and communication intimacy, and discriminant validity by showing its ability to discriminate between maritally distressed and non-distressed couples. The MIQ is a 56-item, Likert-type questionnaire designed to measure communication styles and levels of intimacy among married or cohabitating couples.Subscales on communication, intimacy and satisfaction are correlated in couple-pairs.

Time Frame

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

Title

Marital Intimacy Questionnaire

Description

The Marital Intimacy Questionnaire (MIQ) is a theory-based self-report questionnaire assessing 5 components of marital intimacy. Construct validity was established by examining the correlations of the MIQ with measures of marital satisfaction, perceived global intimacy, and communication intimacy, and discriminant validity by showing its ability to discriminate between maritally distressed and non-distressed couples. The MIQ is a 56-item, Likert-type questionnaire designed to measure communication styles and levels of intimacy among married or cohabitating couples. Subscales on communication, intimacy and satisfaction are correlated in couple-pairs.

Time Frame

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

Title

The Female Sexual Function Index

Description

The Female Sexual Function Index (FSFI) is a 19-item questionnaire, has been developed as a brief, multidimensional self report instrument for assessing the key dimensions of sexual function in women. The Questionnaire described was designed and validated for assessment of female sexual function and quality of life in clinical trials or epidemiological studies.The Female Sexual Function Scale total score is the sum of the 6 domain/subscale scores and has a maximum score of 36. Higher scores indicate better functioning. A total score 26.0 has been validated as a cutoff score for diagnosing Female Sexual Dysfunction.

Time Frame

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

Title

The Female Sexual Function Index

Description

Time Frame

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

Title

Parkinson's Disease Questionnaire-39

Description

Parkinson's Disease Questionnaire-39 (PDQ).is a self report inventory that will be used to access changes in Parkinson's Disease symptoms. The total score for the PDQ is the sum of the scores for the 20 items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero. Individual subscale scores for attention/concentration, retrospective memory, prospective memory, and planning/organization can also be generated by calculating the sum of specific sets of items. The highest possible total for the whole test would be 100; the lowest possible score for the test would be zero.

Time Frame

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

Title

Parkinson's Disease Questionnaire-39

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:(Control Group: 6 healthy, normal couple pairs) 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. Inclusion Criteria for Female Partner in Couple Pairs in Parkinson's Group who has Parkinson's Disease 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. Inclusion Criteria for Second Partner with No PD in Couple Pairs in Parkinson's Group 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. Exclusion Criteria: (In Control Couple Pairs and in Couple Pairs Group in which the Female member has PD) 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. 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrew B Newberg, MD

Phone

215-503-9070

andrew.newberg@jefferson.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy A Wintering

Phone

215-503-3423

nancy.wintering@jefferson.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel A Monti, MD,MBA

Organizational Affiliation

TJU, Integrative Medicine and Nutritional Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Wintering, LCSW, CCRP

Phone

215-503-3423

nancy.wintering@jefferson.edu

First Name & Middle Initial & Last Name & Degree

Emily Navarreto, BS

Phone

215-503-4886

emily.navarreto@jefferson.edu

First Name & Middle Initial & Last Name & Degree

Andrew B Newberg, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.

IPD Sharing Time Frame

Study scan report will be offered to the subject after subject completes study

IPD Sharing Access Criteria

Access only to authorized research staff and study participants

Learn more about this trial

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

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