STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications

Not Applicable

• Conditions: Parkinson Disease

• Registration Number: NCT06980935
• Lead Sponsor: Ruijin Hospital

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. 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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-14
• Study First Submitted: 2025-05-11
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-18
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
MDS-UPDRS-Ⅲ scores	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 Outcome Measures

Name	Time	Method
MDS-UPDRS-Ⅲ sub-scores	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.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China