Parkinson's disease
Conditions
Interventions
True stimulation group:Temporal interference stimulation (TIS) will be applied for treatment
the current frequencies will be set at 1300 Hz and 1430 Hz
stimulation duration will be 30 minutes per session, once daily for 10 consecutive days.
Sham stimulation group:The electrode placement, current intensity, and frequency in the sham stimulation group will be identical to those in the TIS group but will not elicit any physiological effects
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 40 years; 2.Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition)); 3.No medication adjustment in the 4 weeks before and during each stimulation; 4.MDS-UPDRS III score >= 8 points, Hoehn-Yahr score 1-4 points
Exclusion criteria
Exclusion criteria: 1.Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans; 2.Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.); 3.Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment; 4.Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.; 5.A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures; 6.Diagnosed with neuropsychiatric diseases other than Parkinson's disease; 7.A history of drug abuse or drug use; 8.Participated in any clinical trial in the past 6 months; 9.Pregnant/lactating women or subjects (including men) who plan to have children within 6 months; 10.Other situations that the researchers consider unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor Function Assessment (including the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale and the Timed Up and Go test); | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive Function Assessment (including the Mini-Mental State Examination and the Montreal Cognitive Assessment);Activities of Daily Living Assessment (including the Parkinson’s Disease Questionnaire-39, the Pittsburgh Sleep Quality Index, and the Clinical Global Impression Scale);Emotional Assessment (including the Hamilton Anxiety Scale and the Hamilton Depression Scale); | — |
Countries
China
Contacts
Public ContactHu Panpan
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed