NCT07018388

Brief Summary

The goal of this clinical trial is to investigate the therapeutic efficacy of tTIS in patients with Parkinson's disease and to evaluate the immediate effects and conduct intrapatient comparisons of individualized 130 Hz Subthalamic Nucleus-transcranial Temporal Interference Stimulation (STN-tTIS) and Globus Pallidus Internus-transcranial Temporal Interference Stimulation (GPi-tTIS) on motor symptoms in patients with early to mid-stage Parkinson's Disease (PD) during "off" medication states. The main questions this study aims to answer are:

  1. 1.Can tTIS significantly improve the motor symptoms of patients with Parkinson's disease?
  2. 2.Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Apr 2025Nov 2026

Study Start

First participant enrolled

April 23, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 22, 2026

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

June 5, 2025

Last Update Submit

April 20, 2026

Conditions

Parkinson Disease

Keywords

subthalamic nucleusGlobus Pallidus Internustranscranial temporal interference stimulation

Outcome Measures

Primary Outcomes (1)

  • MDS-UPDRS-Ⅲ scores

    The score range for MDS-UPDRS-III is from 0 to 132. The minimum value is 0, indicating no motor impairment, and the maximum value is 132, indicating the most severe motor impairment. Higher scores on the MDS-UPDRS-III indicate worse outcomes, as they reflect greater severity of motor symptoms.

    pre-intervention, immediately after the intervention

Secondary Outcomes (1)

  • MDS-UPDRS-Ⅲ sub-scores

    pre-intervention, immediately after the intervention

Study Arms (3)

STN-tTIS

EXPERIMENTAL

Patients in this group receive 20 minutes of individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ before and after treatment.

Device: NervioX-2400

GPi-tTIS

EXPERIMENTAL

Patients in this group receive 20 minutes of individualized 130 Hz GPi-tTIS sessions targeting the more affected hemisphere during medication "off" and are evaluated for the MDS-UPDRS-Ⅲ both before and after treatment.

Device: NervioX-2400

Sham stimulation

EXPERIMENTAL

Patients in this group receive sham stimulation targeting the subthalamic nucleus in the more affected hemisphere during the medication "off" state, with a stimulation beat frequency of 0 Hz. Each session lasts 20 minutes, and the MDS-UPDRS-III is assessed both before and after treatment.

Device: NervioX-2400

Interventions

NervioX-2400DEVICE

To design the individualized STN-tTIS, each patient completes a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data are used to determine the STN-tTIS montage and stimulation settings through computational modeling.

GPi-tTIS

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of primary Parkinson's disease (MDS);
  • Hoehn \& Yahr stage ≤ 3;
  • Antiparkinsonian drugs must have remained unchanged in the past four weeks, and the dosage must have remained stable throughout the study.

You may not qualify if:

  • Presence of neurological disorders that may affect the study (e.g., traumatic brain injury);
  • Antipsychotics, antidepressants, or dopamine modulators outside of PD drugs;
  • Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers);
  • Unstable vital signs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2025

First Posted

June 12, 2025

Study Start

April 23, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 22, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)