Accelerated temporal interference stimulation of the bilateral subthalamic nuclei for Parkinson's disease
A Single-Center, Double-Blind Randomized Controlled Trial of Accelerated Temporal Interference Stimulation Applied to Bilateral Subthalamic Nucleus for Improving Motor and Vocal Functions in Patients With Parkinson's Disease Or Secondary Parkinson's Syndrome
This study will see if accelerated temporal interference stimulation applied to both subthalamic nuclei helps improve movement and speech in people with Parkinson's disease or secondary parkinsonism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 85 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07568067 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults under 80 with idiopathic Parkinson's disease or secondary parkinsonism at Hoehn–Yahr stage 1.5–3 who can follow instructions, tolerate MRI, and have no prior DBS.
Not a fit: Patients with advanced disease (Hoehn–Yahr >3), prior DBS, significant cognitive impairment, other major neurological or psychiatric disorders, severe organ dysfunction, MRI incompatibility, or age over 80 are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this noninvasive stimulation approach could reduce motor and speech symptoms and provide an alternative to invasive deep brain stimulation for some patients.
How similar studies have performed: Temporal interference is a novel noninvasive deep-brain stimulation technique with encouraging preclinical and early-phase pilot data but limited clinical evidence for subthalamic stimulation in Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.