MAPT Haploid H1b and the Damage of BBB in Dorsal Medulla Oblongata and Autonomic Dysfunction in PD

Study Overview
=================
Brief Summary
-----------------
This study mainly explored the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Detailed Description
-----------------
According to the MDS 2015 clinical diagnostic criteria for Parkinson's disease and the diagnostic criteria for autonomic dysfunction (AutD), the patients were divided into PD with AutD group and PD without AutD group. DCE results, pet-pdrp+18f-dopa data and clinical evaluation (SCOPA-AUT, HRV and sleep EEG) were analyzed; Blood samples were collected to detect MAPT gene polymorphism, oligomers and phosphorylated synuclein. To explore the relationship between the permeability of the blood-brain barrier in the dorsal medulla oblongata and autonomic dysfunction, and the relationship and mechanism of MAPT genotype on the permeability of the blood-brain barrier and the progression of autonomic dysfunction in PD patients.

Official Title
-----------------
Study on the Correlation Between MAPT Haploid H1b and the Damage of Blood-brain Barrier in Dorsal Medulla Oblongata and Autonomic Dysfunction in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Autonomic dysfunction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet the diagnostic criteria for idiopathic PD of MDS 2015 Age ≥ 45 years old Be able to complete various clinical evaluations and scales; Willing to participate in MRI, no contrast agent allergy Exclusion Criteria: Dementia was diagnosed before or 1 year after the onset of motor symptoms Single gene form of PD Coexisting neuropathological diagnosis considered to affect PD progression Known complications affecting BBB (severe infection, cerebral infarction, etc. Such as comorbidities known to affect the autonomic nervous system (e.g., diabetes gangliopathy or neuropathy) Disturbance of consciousness, serious cerebral hemorrhage or cerebral thrombosis, serious brain tumor or brain surgery history, serious mental illness or other serious nervous system diseases, which are enough to seriously interfere with the subjects' motor and non motor symptoms According to the judgment of the researcher, the researcher is unable to complete the research test according to the requirements of the research scheme.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PD with AutD<br>Parkinson's disease with autonomic dysfunction | Other: Autonomic dysfunction<br>* Autonomic dysfunction<br>|
| PD without AutD<br>Parkinson's disease without autonomic dysfunction | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAPT genotype | MAPT mainly has two extended haplotypes (H1 and H2) . | baseline | 
| Dynamic changes of the permeability of blood-brain barrier in dorsal medulla oblongata | Dynamic contrast-enhanced MRI is used to measure the permeability of blood-brain barrier in dorsal medulla oblongata.Dynamic contrast ⁃ enhanced (DCE) ⁃ MRI is a very valuable quantitative MRI technology, which plays a great role in clinical research. Quantitative analysis can calculate the contrast agent concentration in the region of interest, and then improve the comparability of different research results. The permeability of blood-brain barrier is calculated by the volume transfer constant (Ktrans) between plasma and extravascular-extracellular space. | baseline,the sixth month,1year | 
| Dynamic changes of SCOPA-AUT scale | The Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) is used to evaluate autonomic nerve dysfunction. The SCOPA-AUT consists of 25 items assessing the following regions: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women) dysfunction.Higher scores mean more severe autonomic dysfunction, with a minimum score of 0 and a maximum of 69. | baseline,the sixth month,1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, MAPT genotype, autonomic dysfunction, blood brain barrier