๐ฌIn plain words
What the trial is, and whether it could suit you
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).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 โฅ 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.
๐
What it tests
- real transcranial temporal interference stimulation
- sham transcranial temporal interference stimulation
Shanghai General Hospital
Shanghai, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.