Clinical trial NCT05103618: Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA
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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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).

Eligibility 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).

Primary outcomes:
measure: FDOPA PET
timeFrame: Subjects will receive FDOPA imaging at baseline
measure: FDOPA PET
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes in Dopaminergic Function.]
Secondary outcomes:
Other outcomes:
measure: The Speilberger State Trait Anxiety Inventory
timeFrame: These will be obtained initially at baseline or the first imaging appointment
measure: The Speilberger State Trait Anxiety Inventory
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
measure: The Profile of Moods Scale
timeFrame: These will be obtained initially at baseline or the first imaging appointment
measure: The Profile of Moods Scale
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
measure: The Beck Depression Inventory
timeFrame: Subjects will be obtained initially at baseline or the first imaging appointment
measure: The Beck Depression Inventory
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
measure: Marital Intimacy Questionnaire
timeFrame: Subjects will be obtained initially at baseline or the first imaging appointment
measure: Marital Intimacy Questionnaire
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
measure: The Female Sexual Function Index
timeFrame: Subjects will be obtained initially at baseline or the first imaging appointment
measure: The Female Sexual Function Index
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
measure: Parkinson's Disease Questionnaire-39
timeFrame: Subjects will be obtained initially at baseline or the first imaging appointment
measure: Parkinson's Disease Questionnaire-39
timeFrame: Change from Baseline at 60-90 days ( approximately 2-3 months) to access changes
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Marcus Institute of Integrative Health Centers
state: Pennsylvania
Study officials:
affiliation: TJU, Integrative Medicine and Nutritional Sciences
name: Daniel A Monti, MD,MBA
role: STUDY_CHAIR
References: