STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

NCT06980935 | Enrolling By Invitation

• 1 other identifier: 2025140A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Does the therapeutic effect of STN - tTIS relate to medication?
2. 2.The degree of improvement in motor symptoms of Parkinson's disease patients after STN - tTIS therapy under different medication conditions.
3. 3.Visit the clinic once every 1 weeks for therapy and test.
4. 4.Record their symptoms and scores.

Conditions

Parkinson Disease

Keywords

subthalamic nucleus; transcranial temporal interference stimulation; MDS-UPDRS-Ⅲ

Outcome Measures

Primary Outcomes (1)

• MDS-UPDRS-Ⅲ scores

  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.

  pre-intervention, immediately after the intervention

Secondary Outcomes (1)

• MDS-UPDRS-Ⅲ sub-scores

  pre-intervention, immediately after the intervention

Study Arms (2)

Only use STN - tTIS therapy.

EXPERIMENTAL

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.

Device: NervioX-2400

STN - tTIS therapy is used in combination with medication.

EXPERIMENTAL

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.

Device: NervioX-2400

Interventions

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.

Only use STN - tTIS therapy.; STN - tTIS therapy is used in combination with medication.

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 20, 2025
• Study Start: April 14, 2025
• Primary Completion: May 15, 2025
• Study Completion: May 18, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-04

Locations

CN (1)