NCT06980935

STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-04-14
• Primary completion: 2025-05-15
• Completion: 2025-05-18
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

1 site across 1 country: China