Exploring how taVNS affects motor symptoms in Parkinson's disease
Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
This study is testing if a new type of nerve stimulation can help improve movement problems in people with Parkinson's disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06409338 on ClinicalTrials.gov |
What this trial studies
This study investigates the neural mechanisms by which transcutaneous auricular vagus nerve stimulation (taVNS) may alleviate motor deficits in patients with Parkinson's disease. Participants are divided into two groups: one receiving active taVNS and the other receiving sham stimulation, both undergoing treatment for fourteen consecutive days. Motor symptoms and cortical activity are assessed before and after the intervention using advanced techniques like Functional near-infrared spectroscopy and Transcranial magnetic stimulation. The goal is to understand how taVNS influences the balance of excitation and inhibition in the primary motor cortex.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 to 80 with idiopathic Parkinson's disease at Hoehn and Yahr stage ≤2 and stable medication for at least one month.
Not a fit: Patients with cognitive impairment, severe tremor, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of motor symptoms in Parkinson's disease patients.
How similar studies have performed: While the specific application of taVNS in Parkinson's disease is novel, similar neuromodulation techniques have shown promise in other neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) had a diagnosis of idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD and ON-medication Hoehn and Yahr (H\&Y) stage ≤2, * (2) had stable pharmacotherapy for PD at least one month prior to the study, * (3) were aged between 40 and 80, * (4) signed written informed consent, * (5) can cooperate with the testing and taVNS treatment. Exclusion Criteria: * (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) \< 24; * (2) with severe tremor or levodopa-induced dyskinesia; * (3) with current intake of anticholinergics or any drugs that could induce cerebral functional change; * (4) with taVNS contraindications; * (5) received VNS treatment during the past six month; * (6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.
Where this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Zhang Kezhong — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Zhang Kezhong
- Email: kezhong_zhang1969@126.com
- Phone: 13770840575
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.