MRI-Guided Temporal Interference Stimulation for Parkinson's Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease (PD)
• Intervention / Treatment: Device: Temporal Interference Stimulation (130 Hz)

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Temporal Interference Stimulation (130 Hz); 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.
Active Comparator: 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).	Device: Temporal Interference Stimulation (130 Hz); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of SAE	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	All-cause mortality	1month after randomization

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 10, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson Disease; Temporal Interference Stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 20260599

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No