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This study aimed to observe the clinical efficacy and safety of single-target transcranial temporal stimulation (tTIS) intervention in Parkinson's disease (PD) patients and explore the neurophysiological mechanism of TIS intervention. The study was designed as a three-arm (A: GPi group, B: STN group, C: Sham group), randomized, double-blind, parallel-controlled trial. PD patients in the drug-off state (≥12 hours after drug withdrawal) were randomly assigned to receive either tTIS or sham stimulation targeting GPi/STN, with each stimulation lasting 30 minutes. Clinical symptom assessments were conducted before and after the intervention, and safety was monitored by researchers throughout the process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPi group | Experimental |
| |
| STN group | Experimental |
| |
| Sham group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Stimulation | Other | Temporal Interference Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| The part III of MDS-Unified Parkinson's Disease Rating Scale | Baseline,Immediately after a single stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junjun Wu | Contact | +86 0551 62923704 | 2445011385@stu.ahmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline,Immediately after a single stimulation |
| Upper and lower limb alternation | Baseline,Immediately after a single stimulation |
| Clinical Global Impression | 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). | Baseline,Immediately after a single stimulation |
| Resting-state electroencephalogram(rsEEG) | Baseline,Immediately after a single stimulation |
| Transcranial Magnetic Stimulation-Electroencephalography(TMS-EEG) | Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a technique used to assess cortical excitability and causal network connectivity. | Baseline,Immediately after a single stimulation |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |