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| ID | Type | Description | Link |
|---|---|---|---|
| 11932013 | Other Grant/Funding Number | National Natural Science Foundation of China |
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The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIs-Group | Experimental | Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a four-week intervention period. |
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| Sham-TIs Group | Sham Comparator | Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. The sham procedure consists of 28 sessions delivered over a four-week period, without therapeutic stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based Transcranial Temporal Interference Stimulation (HB-TIS) | Device | Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants will receive one stimulation session per day, seven days per week, for four weeks in a home-based setting under real-time remote supervision. The electrode placement is based on a standard 10-10 electroencephalography (EEG) system. For stimulation targeting the right GPi, electrode pairs will be positioned at CP3-CP6 and F3-F6; for stimulation targeting the left GPi, electrode pairs will be positioned at CP4-CP5 and F4-F5. The sham TIS condition uses the same setup and procedures but does not deliver effective stimulation, thereby maintaining blinding. |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) | Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome). | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| The time to complete 3-meter instrumented Timed Up and Go (iTUG) test | Participants will wear six wearable sensors of Mobility Lab system (Clario, Philadelphia, PA) to measure the kinematic data when performing iTUG test. In each trial, participants will be asked to stand up from a chair, walk straightforward for 3 meters, make a 180-degree turn, walk back straightly to the chair and sit down. | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG | Time (in seconds) required to stand up from a seated position and return to sitting during the 3m-iTUG test, in which participants stand up from a chair, walk 3 meters, perform a 180-degree turn, walk back, and sit down. Lower values indicate better performance. | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Liu, Prof. | Contact | +86 21 65507351 | yuliu@sus.edu.cn | |
| Zijun Lu | Contact | +86 21 65507862 | luzijun@snnu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai University of Sport | Not yet recruiting | Shanghai | Shanghai Municipality | 200438 | China |
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| Turning time during 3m-iTUG | Time (in seconds) required to complete the 180-degree turn during the 3m-iTUG test, which includes standing up from a seated position, walking 3 meters, turning, walking back, and sitting down. Lower values indicate better performance. | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Response rate of MDS-UPDRS-III and gait speed | The number of participants who had a clinically meaningful improvement after the stimulation within each group. Clinically meaningful improvement will be defined as a reduction of ≥ 5 points in the MDS-UPDRS-III total score. For gait outcomes, an increase in gait speed of ≥ 0.10 m/s or ≥ 10% improvement from baseline will be considered meaningful | Baseline, immediately after 1 and 4 weeks of intervention |
| MDS-UPDRS-III sub scores | Absolute change from baseline in four prespecified MDS-UPDRS-III sub scores in medication- "ON" and- "OFF" states, including rigidity, bradykinesia, tremor, and axial symptoms, with higher scores indicating more severe motor impairment (worse outcome). | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Geriatric Anxiety Inventory (GAI) | A 20-item self-report scale (range: 0-20), with higher scores indicating greater anxiety severity; scores ≥8-10 suggest clinically relevant anxiety. | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Geriatric Depression Scale (GDS) | A 15-item self-report scale (range: 0-15), with higher scores indicating greater depressive symptom severity; categorized as normal (0-4), mild (5-8), moderate (9-11), and severe (12-15). | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) | a 25-item self-report scale assessing autonomic dysfunction in Parkinson's disease (range: 0-69), with higher scores indicating more severe autonomic symptoms. | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Montreal Cognitive Assessment (MOCA) | a 30-point screening tool (range: 0-30), with lower scores indicating worse global cognitive function. | Baseline, after 4 weeks of intervention |
| Trail Making Test (Part A/B) | The Trail Making Test assesses processing speed (Part A) and executive function (Part B), with longer completion times indicating poorer cognitive performance. | Baseline, after 4 weeks of intervention |
| The Digit Span Test evaluates (DST) | The Digit Span Test evaluates (DST) attention and working memory, with higher scores indicating better cognitive performance. | Baseline, after 4 weeks of intervention |
| Parkinson's Disease Sleep Scale-2 (PDSS-II) | a 15-item scale (range: 0-60), with higher scores indicating more severe sleep disturbances. | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Epworth Sleeping Scale (ESS) | an 8-item scale (range: 0-24), with higher scores indicating greater daytime sleepiness; scores ≥10 suggest excessive daytime sleepiness. | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | a 39-item questionnaire (range: 0-100, scaled), with higher scores indicating poorer quality of life. | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention |
| Home Diary Assessment of Motor States | Participants will record daily information including perceived medication- "ON" and- "OFF" periods [ref], time to medication onset, daily physical activity, sleep duration, and the occurrence of any adverse events. | Baseline, immediately after 1, 2, 3, 4 weeks of intervention |
| Safety related outcomes |
| After each intervention session (28 sessions over 4 weeks). |
| Shanghai University of Sport | Recruiting | Shanghai | Shanghai Municipality | 200438 | 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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