STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

NCT ID: NCT06980935

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2025-05-18

Brief Summary

The goal of this clinical trial is to evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:

1. Does the therapeutic effect of STN - tTIS relate to medication?

2. The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.

Researchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.

1. Visit the clinic once every 1 weeks for therapy and test.

2. Record their symptoms and scores.

Detailed Description

This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are assessed before and after each treatment.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Only use STN - tTIS therapy.

Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "off" (≥12 hours withdrawal) and were evaluated for the MDS - UPDRS - III before and after treatment.

Group Type: EXPERIMENTAL

NervioX-2400

Intervention Type: DEVICE

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

STN - tTIS therapy is used in combination with medication.

Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere's STN during medication "on" and were evaluated for the MDS - UPDRS - III before and after treatment.

Group Type: EXPERIMENTAL

NervioX-2400

Intervention Type: DEVICE

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

Interventions

NervioX-2400

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• MDS diagnosis of primary Parkinson's disease
• Hoehn & Yahr stage < 3
• Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during 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 other than PD drugs
• Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers)
• Unstable vital signs

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

2025140A

Identifier Type: -

Identifier Source: org_study_id