MRI-Guided Temporal Interference Stimulation for Parkinson's Disease
14 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
26
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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.
|
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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Délai: at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
|
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.
|
at pre-stimulation baseline, immediately after stimulation, and at 30 and 60 minutes post-stimulation
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The incidence of SAE
Délai: 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.
|
The incidence of SAE
|
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.
|
|
All-cause mortality
Délai: 1month after randomization
|
All-cause mortality
|
1month after randomization
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 septembre 2026
Achèvement primaire (Estimé)
10 juin 2027
Achèvement de l'étude (Estimé)
10 juin 2027
Dates d'inscription aux études
Première soumission
14 septembre 2026
Première soumission répondant aux critères de contrôle qualité
14 septembre 2026
Première publication (Réel)
18 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20260599
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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