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Enrolling by Invitation

NCT Number: NCT06980935

STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NervioX-2400

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.

Primary outcomes

  1. MDS-UPDRS-Ⅲ scores

    Time frame: pre-intervention, immediately after the intervention

    The score range for MDS-UPDRS-Ⅲ is from 0 to 132. Minimum Value: 0, indicating no motor impairment. Maximum Value: 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.

Secondary outcomes

  1. MDS-UPDRS-Ⅲ sub-scores

    Time frame: pre-intervention, immediately after the intervention

    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.

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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