Parkinson’s disease
Conditions
Interventions
Experimental group:transnasal injection of normal saline
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 50-75 years old (including critical value), regardless of gender; 2. The diagnosis was consistent with MDS, and Parkinson's disease was clinically diagnosed; 3. Course of disease >= 5 years; 4. According to the mds-updrs score scale, Hoehn Yahr grade of drug treatment in "off" stage was grade 3; 5. Stable use of equivalent dopamine dose >= 300 mg / day for at least 1 month before enrollment; 6. After STN-DBS operation, the doctor confirmed that there was no obvious side effect of non motor symptoms caused by DBS stimulation 7. The patient and / or his / her legal guardian agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected to be allergic to the ingredients of the test preparation or serious adverse reactions, or allergic constitution; 2. Parkinson's syndrome and Parkinson's syndrome caused by drugs (such as metoprolol, flunarizine), metabolic diseases (Wilson's disease), encephalitis and CNS degenerative diseases (such as young Huntington's disease, progressive supranuclear palsy, multiple system atrophy) or basal ganglia diseases (such as Fahr's disease or syndrome, etc.), Parkinson's syndrome and Parkinson's syndrome (patients with definite lesions in basal ganglia confirmed by CT or MRI within 2 years and not belong to the original disease) Primary PD; 3. PD patients who have received surgical treatment or received surgical treatment during the planned trial period; 4. Those who have received deep brain stimulation or embryo tissue transfer; 5. Patients with bilateral nasal diseases or not suitable for inclusion according to the researcher's judgment; 6. There are the following cardiovascular and cerebrovascular conditions: (1) Clinically significant heart disease occurred within 6 months before enrollment, including congestive heart failure, unstable angina (angina symptoms at rest), new angina (3 months before enrollment) or myocardial infarction with greater severity than NYHA II-IV; (2) Ventricular arrhythmias requiring antiarrhythmic drugs; QTc > 470ms; hypertension without good control (systolic blood pressure > 150mmhg or diastolic blood pressure > 100mmhg); (3) Thrombotic or embolic venous or arterial events, such as cerebrovascular accidents, including transient ischemic attack, stroke, arterial thrombosis, deep venous thrombosis and pulmonary embolism, occurred within 6 months before enrollment 7. The researchers judged that mental disorders were not suitable for inclusion; 8. Patients with autoimmune disease, immunodeficiency disease or history of organ transplantation; 9. HIV, syphilis, hepatitis C virus, hepatitis B virus infection, or need to use antibiotics for systemic treatment of severe infection; 10. Currently receiving active treatment for CNS diseases (such as sedatives, hypnotics, antidepressants, and antianxiety drugs), unless the dosage has been stable for at least 28 days prior to enrollment and may remain stable during the study period; 11. Patients with history of epilepsy; 12. Patients with tumor or history of tumor; 13. Patients with liver and kidney diseases with clinical significance; 14. Having a history of alcohol or drug abuse in the past 5 years; 15. Those who have used stem cell therapy or participated in stem cell clinical research before; 16. The researcher believes that there is any unstable disease or disease that may endanger the safety and study compliance of patients; 17. Patients who have received other clinical studies within 3 months before enrollment or during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;MDS-UPDRS;Evaluation of non-motor symptoms in Parkinson's disease, Mental State Examination; Cognitive assessment; Depression; anxious; scale; | — |
Countries
China
Contacts
Public Contactwuxi
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed