STN-tTIS with Different Intervals Compared to Standard Parkinson’s Medicine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter trial compares several regimens of STN-tTIS administered at different intervals (once weekly, twice weekly, and five times weekly) against standard antiparkinsonian medication. The goal is to see which interval best improves motor function over a 2-week treatment period and how durable any benefits are after treatment ends. Participants are adults with idiopathic PD, stabilized on medications, and with mid-range disease severity. The approach targets the subthalamic nucleus noninvasively using tTIS. Safety and efficacy data will be collected to determine if interval frequency influences outcomes and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.Aged 50-85 years, male or female.
* 2.Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.
* 3.Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.
* 4.Hoehn and Yahr stage 1-3 in the medication ON state.
* 5.Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.
* 6.No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.
* 7.Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.
* 8.Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.

Exclusion Criteria:

* 1.Other neurological disorders that may affect motor or cognitive function.
* 2.Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.
* 3.History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.
* 4.Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.
* 5.Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.
* 6.Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.

Where it's running

• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Chencheng Zhang, MD, PHD
• Email: i@cchang.org
• Phone: 13381827024

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.