Parkinson s Disease
Conditions
Keywords
Parkinson s Disease, Temporal Interference Stimulation
Brief summary
This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.
Interventions
OTHERTemporal Interference Stimulation
Temporal Interference Stimulation
Sponsors
The First Affiliated Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
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 3 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 |
|---|---|
| The part III of MDS-Unified Parkinson's Disease Rating Scale | Baseline，Immediately after a single stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hoehn-Yahr Stage Scale | Baseline，Immediately after a single stimulation | — |
| 3-Meter Timed Up and Go Test | Baseline，Immediately after a single stimulation | — |
| 10-meter walking test | Baseline，Immediately after a single stimulation | — |
| Upper and lower limb alternation | Baseline，Immediately after a single stimulation | — |
| Clinical Global Impression | Baseline，Immediately after a single stimulation | CGI comprehensively quantifies the severity of a patient's illness and the net benefit of treatment by assessing disease severity (CGI-S), overall improvement (CGI-I), and the balance between efficacy and side effects (Efficacy Index EI). |
| Resting-state electroencephalogram（rsEEG） | Baseline，Immediately after a single stimulation | — |
| Transcranial Magnetic Stimulation-Electroencephalography（TMS-EEG） | Baseline，Immediately after a single stimulation | Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity. |
Countries
China
Outcome results
None listed