Parkinson's disease
Conditions
Interventions
Sham group:null stimulation
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with a diagnosis of PD based on UK Brain Bank Criteria as confirmed by a neurologist; 2. Hoehn and Yahr stage in the on-medication state of 2.5 or less; 3. In principle, the pharmacological regimen remains unchanged during LIPUS treatment; 4. Men and women, ranging in age from 18 to 80 years old; 5. Available to participate in follow-up for the duration of study and give consent; 6. Subjects are examined by transcranial sonography, having a sufficient temporal bone window and substantia nigra (SN) and striatum echogenicity (contralateral and ipsilateral) so that they can be targeted by a wearable LIPUS device.
Exclusion criteria
Exclusion criteria: 1. Hoehn-Yahr stage greater than or equal to 2.5; 2. A score of 3 or 4 on items 4.1 and 4.2 of the UPDRS scale, indicating the presence of severe dyskinetic symptoms; 3. Presence of other neurodegenerative diseases (Parkinson-plus syndromes, Lewy body dementia, Alzheimer's disease, ALS, etc.); 4. History of hemorrhagic stroke or severe head trauma; 5. Multiple ischemic stroke history, or acute ischemic stroke within the past 6 months; 6. Subjects with malignant brain tumors or a history of seizures within the past year; 7. Pregnant and lactating women, patients with implanted cardiac pacemakers, or those on long-term anticoagulant therapy (e.g., warfarin); 8. Subjects with drug-induced parkinsonism; 9. Subjects who have undergone deep brain stimulation (DBS) or neuroablative surgery; 10. Subjects with significant cognitive impairment, with a Montreal Cognitive Assessment (MoCA) score 14); 13. Subjects with a history of alcoholism or drug addiction; 14. Subjects with severe hepatic or renal dysfunction; 15. Subjects unable to communicate with researchers or staff, or who are participating in other clinical studies simultaneously.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| UPDRS(Unified Parkinson's Disease Rating Scale) score III; | — |
Secondary
| Measure | Time frame |
|---|---|
| the Mini-Mental State Examination (MMSE);PDQ(Parkinson's Disease Questionnaire)-39;18F-FDG(18F-fluro-2-deoxyglucose) PET(positron emission computed tomography) targets glucose metabolism in the brain;fNIRs(functional near - infrared spectroscopy);high-density electroencephalography;gait analysis;functional magnetic resonance imaging (fMRI);the Montreal Cognitive Assessment (MoCA);the Beck Depression Inventory (BDI);the Beck Anxiety Inventory (BAI);the Parkinson's Disease Sleep Scale (PDSS);The Rapid eye movement sleep Behavior Disorder Screening Questionnaire (RBDSQ);UPDRS (Unified Parkinson's Disease Rating Scale) score I, II, IV; | — |
Countries
China
Contacts
Public ContactZheng Yuanyi
Shanghai Sixth People's Hospital
Outcome results
None listed