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Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• Aged 50-85 years, male or female.

• Diagnosed with clinically established or clinically probable Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.

• Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.

• Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.

• Written informed consent signed by the study participant.

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xiaoying Zhu, MD
docxiaoying@163.com
86-13817659260
Backup
Jingtao Feng, MD
fengjt0919@163.com
86-18651285832
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2027-04
Participants
Target number of participants: 32
Treatments
Experimental: the experimental group
real stimulation
Sham_comparator: the control group
sham stimulation
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov