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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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This clinical trial will evaluate the efficacy of accelerated Temporal Interference Stimulation (TIS) as a therapeutic intervention for individuals diagnosed with Parkinson's disease or secondary Parkinson's syndrome. Accelerated TIS will be delivered targeting the bilateral subthalamic nuclei of the brain. The primary objective is to assess whether accelerated TIS yields measurable improvements in motor performance and verbal speech function among enrolled subjects. Functional magnetic resonance imaging (fMRI) will be adopted as an auxiliary imaging modality to objectively characterize underlying cerebral functional alterations induced by accelerated TIS intervention. The core scientific research questions to be addressed in this trial are listed as follows:
Investigators will implement a four-arm parallel controlled comparative design for all enrolled eligible subjects. All confirmed Parkinson's disease patients will undergo standardized random grouping and be allocated into two independent research arms. Subjects in the experimental arm will receive continuous, standardized accelerated TIS intervention targeting bilateral subthalamic nuclei. Subjects in the control arm will receive matched sham stimulation intervention. Sham stimulation adopts identical operation procedures, equipment wearing mode and on-site operating environment as formal accelerated TIS, with no valid neuromodulation therapeutic effect generated. Identical random grouping, intervention arrangement and controlled research design will be fully implemented in eligible subjects diagnosed with secondary Parkinson's syndrome. Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of accelerated TIS on motor dysfunction and speech impairment in Parkinson-related patients.
All enrolled subjects will complete the following standardized trial procedures in full compliance with the trial protocol:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Stimulation Group-Parkinson's disease | Experimental | Participants diagnosed with Parkinson's disease in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field. |
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| Sham Stimulation Group-Parkinson's disease | Sham Comparator | Participants diagnosed with Parkinson's disease in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition. |
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| Active Stimulation Group- secondary Parkinson's syndrome | Experimental | Participants diagnosed with secondary Parkinson's syndrome in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporal Interference Stimulation | Device | Sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation, administered twice daily (40 minutes per session, ≥1 hour rest interval between sessions). Stimulation targets are bilateral STN, with individualized electrode placement and current intensity determined via personalized modeling from patient MRI data. Active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field. |
| Measure | Description | Time Frame |
|---|---|---|
| The score of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) | The MDS-UPDRS-III is a standardized assessment tool to evaluate motor function symptoms in people with Parkinson's disease.It has a scoring range of 0 to 132 points, with higher scores meaning more severe motor disorders. | From enrollment to 1 month after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of Mini-BESTest | The Mini-BESTest is a clinical assessment tool for evaluating balance function. It assesses the balance control system across multiple domains, with a scoring range of 0 to 28 points; higher scores indicate better balance function. | From enrollment to 1 month after treatment |
| 10-Meter Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zi Dan | Contact | +86 18922465578 | zidan@mail2.sysu.edu.cn | |
| Liu Hanjun | Contact | +86 15920175118 | lhanjun@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Sham Stimulation Group- secondary Parkinson's syndrome | Sham Comparator | Participants diagnosed with secondary Parkinson's syndrome in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition. |
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| Temporal Interference Stimulation | Device | Sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation (sham control), administered twice daily (40 minutes per session, ≥1 hour rest interval between sessions). Stimulation targets are bilateral STN, with individualized electrode placement and current intensity determined via personalized modeling from patient MRI data. Sham stimulation uses two identical high frequencies (2000 Hz and 2000 Hz) to eliminate the therapeutic interference effect, matching all other procedural details to the active stimulation arm. |
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The 10-Meter Walk Test assesses gait speed and functional mobility by measuring the time required to walk 10 meters. Increased time reflects slower walking and worse mobility. |
| From the enrollment to 1 month after treatment |
| Voice intensity | Voice intensity is measured using Praat software. Voice intensity, expressed in dB SPL, reflects the loudness of the voice. This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in voice intensity may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention. | From the enrollment to 1 month after treatment |
| Velocity of center of pressure (COP) sway | Center of pressure (COP) sway velocity of subjects on stable and unstable surfaces is measured via a balance board, recording COP movement speed during standing. This indicator objectively assesses balance control and adaptability to different surfaces; abnormal increases indicate impaired balance, aiding evaluation of balance disorder severity and intervention effectiveness. | From the enrollment to 1 month after treatment |
| BOLD-fMRI | Functional MRI is used to acquire BOLD data. BOLD signals reflect regional brain activity and functional connectivity. This measure evaluates brain function and structural connectivity associated with motor and cognitive performance. | From the enrollment to 1 month after treatment |
| Phonation duration | Phonation duration refers to the continuous time of voluntary phonation. This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in phonation duration may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention. | From the enrollment to 1 month after treatment |
| Fundamental frequency (F₀) | Fundamental frequency (F₀) range of subjects' phonation is measured using Praat software. Fundamental frequency range is the interval between the minimum and maximum F₀ (unit: Hz) during phonation, reflecting the variability of voice pitch. This indicators is used to objectively evaluate the functional status of the subjects' vocal system. Abnormalities in F₀ range may indicate impairments in vocal cord movement, laryngeal muscle control, or related neural regulation, which is of great significance for assessing the severity of vocal function disorders and the effect of intervention. | From the enrollment to 1 month after treatment |
| Range of center of pressure (COP) sway | Center of pressure (COP) sway range of subjects on stable and unstable surfaces is measured via a balance board, recording COP movement maximum horizontal displacement during standing. This indicator objectively assesses balance control and adaptability to different surfaces; abnormal increases indicate impaired balance, aiding evaluation of balance disorder severity and intervention effectiveness. | From the enrollment to 1 month after treatment |
| Diffusion Tensor Imaging(DTI) | Functional MRI is used to acquire Diffusion Tensor Imaging(DTI) data. DTI characterizes white matter microstructural integrity and fiber tract organization. This measure evaluates brain function and structural connectivity associated with motor and cognitive performance. | From the enrollment to 1 month after treatment |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D010302 | Parkinson Disease, Secondary |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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