STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NervioX-2400.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease
Overview
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.
Interventions
- 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.
Primary outcome measures
- MDS-UPDRS-Ⅲ scores [Time frame: pre-intervention, immediately after the intervention]
Secondary outcome measures (1)
- MDS-UPDRS-Ⅲ sub-scores [Time frame: pre-intervention, immediately after the intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT06980935 · 2025140A