STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

Shanghai Jiao Tong University

Status: Invitation-only

Conditions: Parkinson Disease

Treatments: Device: NervioX-2400

Study type: Interventional

Funder types: Other

Identifiers

NCT06980935

2025140A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Only use STN - tTIS therapy.

Experimental group

Description:

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.

Treatment:

Device: NervioX-2400

STN - tTIS therapy is used in combination with medication.

Experimental group

Description:

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.

Treatment:

Device: NervioX-2400