Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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)
Facility
City
Region
Status
Shanghai General Hospital
Shanghai
Shanghai Municipality
Recruiting
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
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.
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