Intrapatient Comparison of STN and GPi tTIS in PD

N/AEnrolling By InvitationNCT07018388

Ruijin Hospital20 enrolled

Overview

The goal of this clinical trial is 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 "on" medication states. The main questions this study aims to answer are: 1. Is the therapeutic effect of STN-tTIS superior to that of GPi-tTIS? 2. What is the degree of improvement in motor symptoms of Parkinson's Disease patients after receiving STN-tTIS or GPi-tTIS during the "on" medication phase? Researchers will compare the MDS-UPDRS-III improvement scores of tTIS therapy at different targets. Participants are required to: 1. Visit the clinic twice within two weeks for therapy and testing. 2. Record their symptoms and scores.

This clinical trial aims to explore which targets are better for improving PD motor symptoms. Patients were randomly assigned to either Group A or Group B. Group A first received STN-tTIS therapy, followed by GPi-tTIS therapy; Group B received the treatments in the reverse order. Each session lasted 20 minutes, and patients were in the on-medication state for both treatments. The order of sessions was randomized, with at least 7 days of washout between sessions to avoid carryover effects. MDS-UPDRS-III evaluations were assessed before and after each treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Parkinson Disease

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.

NervioX-2400DEVICE

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Presence of neurological disorders that may affect the study (e.g., traumatic brain injury); * History of 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.

Outcomes

Primary Outcomes

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.

Time frame: pre-intervention, immediately after the intervention

Secondary Outcomes

MDS-UPDRS-Ⅲ sub-scores

The MDS-UPDRS-III assesses motor symptoms in Parkinson's disease through sub-scores: Tremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors. Rigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement. Axial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments.