Effect of Meditation and Controls and Subjects With Parki... | NCT05103618

Status Module

Description Module

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).

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The Speilberger State Trait Anxiety Inventory	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.

Eligibility Module

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).

ID	Term
D010300	Parkinson Disease
D019636	Neurodegenerative Diseases
D002493	Central Nervous System Diseases
D009069	Movement Disorders

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D009422	Nervous System Diseases
D000080874	Synucleinopathies