Different Frequency Temporal Interference Stimulation for Parkinson’s Disease

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

Participants with idiopathic Parkinson’s disease will receive accelerated Temporal Interference Stimulation targeting the bilateral subthalamic nuclei. One side will be stimulated at 130 Hz and the other at 60 Hz, tailored to each patient’s dominant symptoms. The study uses functional MRI as an imaging tool to characterize brain changes associated with the stimulation. The primary outcomes focus on motor performance and verbal speech function, with participants staying on stable levodopa therapy during the trial. This is an interventional investigation conducted at a single center in Guangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Dan Zi
• Email: 925343654@qq.com
• Phone: +8618922465578

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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.