Accelerated temporal interference stimulation of the bilateral subthalamic nuclei 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

Investigators will deliver accelerated temporal interference stimulation targeted to the bilateral subthalamic nuclei in ambulatory patients with Parkinson's disease or secondary parkinsonism (Hoehn–Yahr stage 1.5–3). Motor performance and verbal speech function will be measured before and after the intervention to determine clinical effects. Functional MRI will be used as an ancillary imaging tool to characterize stimulation-related changes in brain function. Key exclusions include prior deep brain stimulation, major organ dysfunction, other neurological disease, severe psychiatric illness, MRI contraindications, and age over 80.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Confirmed diagnosis of idiopathic Parkinson's disease or secondary parkinson's syndrome ; Hoehn-Yahr stage 1.5-3.
2. Ability to walk independently.
3. Ability to follow instructions, with no cognitive impairment.
4. Patient and their family agree to cooperate with treatment and provide written informed consent.

Exclusion Criteria:

1. Claustrophobia or presence of metallic implants precluding MRI examination and evaluation.
2. Severe dysfunction of vital organs including heart, lung, liver, kidney, etc.
3. Complicated with other neurological diseases such as cerebral infarction.
4. Presence of mental illness, severe depression, anxiety, etc., which may affect the accuracy of study results.
5. History of deep brain stimulation (DBS) surgery.
6. Patients unable or unwilling to cooperate with scale assessments.
7. Aged over 80 years old.

Where it's running

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

Study contacts

• Study coordinator: Zi Dan
• Email: zidan@mail2.sysu.edu.cn
• Phone: +86 18922465578

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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.