NCT06409338

Research on the Brain Mechanism of taVNS in Regulating PD Motor Symptoms

Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is a double blind comparative study exploring the neural underpinnings of taVNS modulating PD motor deficits. We hypothesize that taVNS might improve PD motor deficits by regulating the balance between excitation and inhibition in the primary motor cortex.

Detailed description

Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Transcutaneous auricular vagus nerve stimulation (active）	Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.
DEVICE	Transcutaneous auricular vagus nerve stimulation (sham）	In the sham stimulation group, the electrodes were fixed at the left earlobe with the same stimulus parameters. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.

Timeline

• Start date: 2024-05-11
• Primary completion: 2024-08-01
• Completion: 2024-09-01
• First posted: 2024-05-10
• Last updated: 2024-07-03

Locations

1 site across 1 country: China