MRI-Guided Temporal Interference Stimulation for Parkinson's Disease
14. september 2026 opdateret af: Tang Zhouping, Tongji Hospital
Efficacy of MRI-Guided Transcranial Temporal Interference Electrical Stimulation (tTIS) Modulation for Parkinson's Disease: An Exploratory Study
This study aims to evaluate the efficacy and safety of tTIS treatment in patients with Parkinson's disease (PD).
The study will enroll eligible PD patients and randomly assign them to two groups: Group A will first receive combined GPi and STN stimulation, followed by GPi stimulation one week later; Group B will first receive GPi stimulation, followed by combined GPi and STN stimulation one week later.
The MDS-UPDRS Part III will be assessed at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation for each session, in order to evaluate and compare the therapeutic effects of tTIS targeting GPi alone versus combined GPi and STN stimulation on motor symptoms in PD patients, and to assess the differential efficacy of tTIS at different targets among PD patients with varying symptoms.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
26
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 18-75 years (inclusive), any gender.
- Diagnosis of idiopathic Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 edition).
- Hoehn and Yahr stage 2-4 (inclusive) during the "off" state.
- Documented response to levodopa (>33% improvement), with a stable anti-parkinsonian medication regimen for at least 4 weeks prior to screening, and no dose adjustments during the study.
- Voluntary signed informed consent, and ability to understand and comply with the study protocol to complete the study.
- No significant cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≥21).
Exclusion Criteria:
Inability or unwillingness to comply with the study protocol and/or inability to provide written informed consent;
Presence of a significant medical condition that may interfere with study procedures or confound the assessment of study endpoints;
Presence of a severe psychiatric disorder that may affect the participant's ability to comply with the study protocol;
A history of psychiatric disorders or current severe depression or anxiety;
Presence of metallic implants in the brain;
Known pregnancy or current breastfeeding;
Severe neurological disorders, such as a brain tumor;
Severe cardiac disease, including the presence of an implanted cardiac pacemaker;
Scalp lesions, inflammation, infection, active bleeding, or an increased bleeding tendency;
Any other current medical condition for which the use of transcranial electrical stimulation may pose an unacceptable risk;
A history of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease;
Inability to undergo magnetic resonance imaging (MRI), such as because of claustrophobia or implanted metallic devices;
Inability to cooperate with or complete the required assessments; or any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Experimental group A
Patients in this group receive individualized targeting based on MRI head modeling.
During the medication-off period, they first undergo 130 Hz combined GPi and STN stimulation (GPi+STN), and one week later, they undergo 130 Hz GPi stimulation alone.
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All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus.
The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation.
Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
|
|
Aktiv komparator: Experimental group B
Patients in this group receive individualized targeting based on MRI head modeling.
During the medication-off period, they first undergo 130 Hz GPi stimulation alone, and one week later, they undergo 130 Hz combined GPi and STN stimulation (GPi+STN).
|
All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus.
The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation.
Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Tidsramme: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
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The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132.
In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment.
Changes in the score reflect the degree of improvement in motor function.
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at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The incidence of SAE
Tidsramme: From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 3 weeks). SAEs will be monitored and recorded continuously throughout this period.
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The incidence of SAE
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From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 3 weeks). SAEs will be monitored and recorded continuously throughout this period.
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All-cause mortality
Tidsramme: 1month after randomization
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All-cause mortality
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1month after randomization
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. september 2026
Primær færdiggørelse (Anslået)
10. juni 2027
Studieafslutning (Anslået)
10. juni 2027
Datoer for studieregistrering
Først indsendt
14. september 2026
Først indsendt, der opfyldte QC-kriterier
14. september 2026
Først opslået (Faktiske)
18. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20260599
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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