Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration
10. července 2026 aktualizováno: Shengdi Chen, Ruijin Hospital
A Study on the Therapeutic Effects and Target Exploration of Temporal Interference-Based Noninvasive Deep Brain Stimulation in Patients With Idiopathic Parkinson's Disease and Parkinsonian Syndromes
This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation.
This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.
Přehled studie
Postavení
Zápis na pozvánku
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Shanghai, Čína
- Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria.
- Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study.
- Hoehn and Yahr (H&Y) stage ≤ 3 in the "ON" medication state.
- Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.
- Able to maintain and cooperate with Parkinson's disease symptom diaries.
- Signed written informed consent.
Exclusion Criteria:
- Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes.
- Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies.
- Orthopedic or other medical conditions that could affect gait or balance.
- Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable.
- History of taking antipsychotic, antidepressant, or other medications that may affect dopamine levels.
- Contraindications to electrical stimulation, such as implanted cardiac pacemakers or a history of epilepsy.
- History of electroconvulsive therapy (ECT).
- Severe comorbidities, including cardiovascular disease, respiratory disease, or hepatic/renal dysfunction.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: GPi TIS
Participants with PD or PDS receive TIS targeting the contralateral globus pallidus internus (GPi).
Each group consists of 10 patients with PD and 10 patients with PDS.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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Experimentální: STN TIS
Participants with PD or PDS receive TIS targeting the contralateral subthalamic nucleus (STN).
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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Experimentální: Putamen TIS
Participants with PD or PDS receive TIS targeting the contralateral putamen.
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
|
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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Experimentální: LHA TIS
Participants with PD or PDS receive TIS targeting the contralateral lateral hypothalamic area (LHA).
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
|
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
|
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Experimentální: Dentate TIS
Participants with PD or PDS receive TIS targeting the ipsilateral cerebellar dentate nucleus.
Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.
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Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with AB sequence (Active → Sham).
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Participants with PD or PDS receive TIS.
Each session lasts 30 minutes for 3 consecutive days.
The study uses a crossover design with BA sequence (Sham → Active).
Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms.
Changes from baseline after real or sham stimulation will be analyzed and compared between groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Secondary motor outcome
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The UMSARS is a rater-administered scale used to assess disease severity in patients with Parkinsonian syndromes, particularly multiple system atrophy.
The total score ranges from 0 to 104, with a higher score indicating greater disease severity.
The change in UMSARS score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Secondary motor outcome
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Freezing of Gait Questionnaire is used to assess the severity and frequency of freezing of gait in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 24, with a higher score indicating more severe freezing of gait.
The change in FOGQ score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Secondary motor outcome
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Berg Balance Scale is a rater-administered scale used to assess balance function and fall risk.
The total score ranges from 0 to 56, with a higher score indicating better balance function.
The change in Berg Balance Scale score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Hamilton Anxiety Rating Scale-14（HAMA-14）is a rater-administered scale used to assess the severity of anxiety symptoms.
The total score ranges from 0 to 56, with a higher score indicating more severe anxiety.
The change in HAMA-14 score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Hamilton Depression Rating Scale-17（HAMD-17）is a rater-administered scale used to assess the severity of depressive symptoms.
The total score ranges from 0 to 52, with a higher score indicating more severe depression.
The change in HAMD-17 score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Mini-Mental State Examination（MMSE）is a brief cognitive screening scale used to assess global cognitive function.
The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
The change in MMSE score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Montreal Cognitive Assessment（MoCA）is a brief cognitive screening scale used to assess global cognitive function, particularly mild cognitive impairment.
The total score ranges from 0 to 30, with a higher score indicating better cognitive function.
The change in MoCA score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Non-Motor Symptoms Scale（NMSS）is a rater-administered scale used to assess the severity and frequency of non-motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 360, with a higher score indicating a greater non-motor symptom burden.
The change in NMSS score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Scales for Outcomes in Parkinson's Disease-Autonomic Dysfunction（SCOPA-AUT）is a patient-reported scale used to assess autonomic symptoms in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 69, with a higher score indicating more severe autonomic dysfunction.
The change in SCOPA-AUT score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The Parkinson's Disease Questionnaire-39 Summary Index（PDQ-39 SI）is a patient-reported scale used to assess health-related quality of life in patients with Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 100, with a higher score indicating poorer quality of life.
The change in PDQ-39 SI score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part I is used to assess non-motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 52, with a higher score indicating more severe non-motor symptom burden.
The change in MDS-UPDRS Part I score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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The MDS-UPDRS Part II is used to assess motor experiences of daily living in patients with idiopathic Parkinson's disease and Parkinsonian syndromes.
The total score ranges from 0 to 52, with a higher score indicating greater motor-related impairment in daily living.
The change in MDS-UPDRS Part II score from baseline to after stimulation will be compared between the real and sham stimulation groups.
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Changes in resting-state EEG β-band oscillation power before and after stimulation
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes
Časové okno: Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Changes in whole-brain resting-state fMRI functional connectivity strength, with exploratory analyses focusing on the sensorimotor and basal ganglia networks, before and after stimulation
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Baseline, 3 days after sham stimulation, and 3 days after active stimulation.
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Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: From baseline through study completion (up to 3 weeks)
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The number and severity of all AEs and SAEs will be collected and monitored throughout the study to evaluate the safety and tolerability of the intervention.
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From baseline through study completion (up to 3 weeks)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
3. července 2026
Primární dokončení (Odhadovaný)
30. září 2026
Dokončení studie (Odhadovaný)
30. září 2026
Termíny zápisu do studia
První předloženo
8. prosince 2025
První předloženo, které splnilo kritéria kontroly kvality
10. července 2026
První zveřejněno (Aktuální)
13. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Klinické studie na AB Temporal Interference Stimulation
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