Effects of long-term vagus nerve stimulation in early Parkinson's disease

A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients

This study is testing if a new type of nerve stimulation can help people with early Parkinson's disease slow down the progression of their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 55 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06665113 on ClinicalTrials.gov

What this trial studies

This study is a randomized, double-blind, controlled trial that investigates the effects of long-term transcutaneous auricular vagus nerve stimulation (taVNS) in patients diagnosed with early-stage idiopathic Parkinson's disease. The aim is to explore this novel therapeutic approach to potentially delay the progression of Parkinson's disease. Participants will receive either real taVNS stimulation or a sham stimulation for comparison. The study will assess the neuroprotective effects of this intervention over time.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 55-75 with early-stage idiopathic Parkinson's disease and a Hoehn and Yahr stage of 2.5 or less.

Not a fit: Patients with cognitive impairments or those on neuroprotective medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new method to slow the progression of Parkinson's disease and improve patient outcomes.

How similar studies have performed: While the approach of taVNS is relatively novel, previous studies on vagus nerve stimulation have shown promising results in other neurological conditions.

Eligibility criteria

Inclusion Criteria:

1. Age 55-75 years.
2. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
3. Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation.
4. Parkinson's disease duration ≤ 3 years.
5. Receiving standard anti-Parkinson's disease medication treatment.

Exclusion Criteria:

1. Patients with cognitive impairment (MMSE \< 24 and/or MoCA \< 26) or mental illnesses, or those unable to cooperate for other reasons.
2. Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01.
3. Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.
4. Previous treatment with vagus nerve stimulation.
5. MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts \> 1 cm³ or \> 3 lacunar infarcts.
6. Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation.
7. Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related.
8. Previous history of stroke or intracranial mass lesions.
9. Patients with existing or potential cardiovascular diseases.
10. Ophthalmic diseases affecting eye movements.
11. Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae).
12. Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.
13. Concurrent participation in other clinical trials.
14. Inability to receive the required treatment and follow-up due to geographic reasons.
15. Any subject with an upper limb UPDRS tremor score of 3 or higher.
16. Patients with a history of PD-related freezing episodes or falls.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Kezhong Zhang, Professor — The First Affiliated Hospital with Nanjing Medical University
• Study coordinator: Kezhong Zhang, Professor

Conditions: Parkinson Disease, Idiopathic, Vagus Nerve Stimulation