Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

Launched by KEZHONG ZHANG · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the potential benefits of a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) for people with early-stage Parkinson's disease. The goal is to see if long-term use of this treatment can help protect the brain and improve the quality of life for patients who have been diagnosed with idiopathic Parkinson's disease within the last three years.

To participate, individuals need to be between 55 and 75 years old and have a specific stage of Parkinson's disease that allows them to still manage daily activities. They should also be receiving standard medications for Parkinson's. However, those with certain health issues, previous treatments that might interfere with the study, or conditions that affect their ability to participate won't be eligible. Participants will be randomly assigned to receive either the taVNS treatment or a placebo (a treatment that looks the same but doesn't have any active medicine) over an extended period. Throughout the trial, participants will be monitored closely to assess any changes in their condition and overall well-being.

Gender

ALL

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.