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Recruiting Not applicable

Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease

NCT07625540 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-05-20
Last updated
2026-06-04

Condition(s) studied

Parkinson's Disease (PD)

Investigational drug(s) / intervention(s)

real transcranial temporal interference stimulationsham transcranial temporal interference stimulation

real transcranial temporal interference stimulation: tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.

sham transcranial temporal interference stimulation: The sham stimulation is administered using the same procedure as the real tTIS.

Study 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

Sex
ALL
Min age
50 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism. * Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery. * Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation. * Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months. * Presence of contraindications to MRI or inability to tolerate MRI examination. * Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance. * New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks. * History of epilepsy. * Pregnancy or breastfeeding. * Any other condition judged by the investigator as unsuitable for participation in the study.

Primary outcome measure(s)

  • Changes of motor function in PD — Changes from baseline after 5 days of intervention (Day 5)
    the scores of UPDRS III \[OFF\])

Trial sites (1)

FacilityCityRegionStatus
Shanghai General Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07625540 on ClinicalTrials.gov ↗ ← All trials in China