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NCT07857824

Temporal Interference Stimulation for Motor and Non-motor Symptoms in Parkinson's Disease

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy of tTIS treatment in improving motor function in patients with Parkinson's disease (PD), as well as its effects on mood, activities of daily living, sleep, cognition, and other functional domains. It also seeks to assess differences in treatment response among PD subtypes (tremor-dominant, rigidity-dominant, and mixed) and across disease stages (early stage, Hoehn and Yahr \[H\&Y\] stages 1-2, and mid-to-late stage, H\&Y stages 2.5-3). The study will enroll eligible PD patients and evaluate their condition using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the 39-item Parkinson's Disease Questionnaire (PDQ-39), the Pittsburgh Sleep Quality Index (PSQI), the Hamilton Anxiety Rating Scale (HAMA), the Hamilton Depression Rating Scale (HAMD), and a visual analog scale (VAS) for fatigue. Assessments will be performed before routine tTIS treatment, immediately after treatment, and at two and four weeks post-treatment, in order to analyze the therapeutic effect of tTIS in PD. This is an observational study without any intervention; all enrolled participants will receive standard medical care and health education.

Official title: A Prospective Observational Cohort Study of Temporal Interference Stimulation Treatment for Improving Motor and Non-motor Symptoms in Patients With Parkinson's Disease

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-10-10

Completion Date

2027-06-10

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DEVICE

transcranial temporal interference stimulation (tTIS)

Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days(only once on the 5th day). Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state.