STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease

Summary

The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease. Previous studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events. The main questions this study aims to answer are: 1. Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period? 2. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms? 3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment? 4. Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety? Participants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.

Eligibility

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.

Conditions2

Interventions1

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