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Different Frequency Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease

RecruitingNAAges any - anyAllKe Dong, MD
NCT07721688 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This clinical trial will evaluate the efficacy of accelerated Temporal Interference Stimulation (TIS) as a therapeutic intervention for individuals diagnosed with Parkinson's disease. Different frequency TIS will be delivered targeting the bilateral subthalamic nuclei of the brain according to the patient's clinical symptoms. Specifically, the basal thalamic nuclei on the side opposite to the side where the patient's symptoms are most severe receive stimulation at 130 Hz, whilst those on the other side receive stimulation at 60 Hz. The primary objective is to assess whether accelerated TIS yields measurable improvements in motor performance and verbal speech function among enrolled subjects. Functional magnetic resonance imaging (fMRI) will be adopted as an auxiliary imaging modality to objectively characterize underlying cerebral functional alterations induced by accelerated TIS interve

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Idiopathic Parkinson's disease diagnosed by neurologists according to the Movement Disorder Society Clinical Diagnostic Criteria; 2. Hoehn and Yahr stage 1.5-3.0; 3. Stable levodopa-based antiparkinsonian medication for at least 4 weeks before enrolment, with no planned medication change during the trial period; 4. Ability to walk independently; 5. Ability to understand and follow study instructions and complete the required assessments, with no severe cognitive impairment as screened by the Montreal Cognitive Assessment and/or Mini-Mental State Examination according to prespecified thresholds; 6. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. Any contraindication to MRI or tTIS, including claustrophobia or ferromagnetic intracranial or subcutaneous implants; 2. Significant systemic disease that could increase study risk or interfere with trial participation; 3. Neurological disorders other than Parkinson's disease; 4. Major psychiatric disorder or severe depression or anxiety; 5. History of deep brain stimulation surgery; 6. Inability or unwillingness to complete all interventions and assessments.
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What it tests

  • Temporal Interference Stimulation
  • Temporal Interference Stimulation
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Where

1 site
Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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