Recruiting
Not applicable
Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease
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
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
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