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The goal of this clinical trial is to investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "off" medication states.
The main questions this study aims to answer are:
This clinical trial aims to verify the efficacy of tTIS in patients with Parkinson's disease and to explore which targets are better for improving PD motor symptoms.Patients were randomly assigned to receive Stimulation Type A, B, or C. Type A received STN-tTIS therapy; Type B received GPi-tTIS therapy; Type C received sham stimulation targeting the subthalamic nucleus.
Each session lasted 20 minutes, and patients were in the off-medication state for all treatments.The order of stimulation types was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STN-tTIS | Experimental | Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-â…¢ before and after treatment. |
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| GPi-tTIS | Experimental | Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-â…¢ both before and after treatment. |
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| Sham stimulation | Experimental | Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NervioX-2400 | Device | To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling. |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS-â…¢ scores | The score range for MDS-UPDRS-III is from 0 to 132. The minimum value is 0, indicating no motor impairment, and the maximum value is 132, indicating the most severe motor impairment. Higher scores on the MDS-UPDRS-III indicate worse outcomes, as they reflect greater severity of motor symptoms. | pre-intervention, immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| MDS-UPDRS-â…¢ sub-scores | The MDS-UPDRS-III assesses motor symptoms in Parkinson's disease through sub-scores: Tremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors. Rigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement. Axial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | China | 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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| NervioX-2400 | Device | To design the individualized GPi-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data is used to determine the GPi-tTIS montage and stimulation settings via computational modeling. |
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| NervioX-2400 | Device | To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling. |
|
| pre-intervention, immediately after the intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |