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

Nanjing Medical University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Transcutaneous auricular vagus nerve stimulation (sham）; Device: Transcutaneous auricular vagus nerve stimulation (active）

Study type: Interventional

Funder types: Other

Identifiers

NCT06409338

2024-SR-235

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Active Transcutaneous auricular vagus nerve stimulation

Active Comparator group

Description:

For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 14 consecutive daily sessions of taVNS.

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation (active）

Sham Transcutaneous auricular vagus nerve stimulation

Sham Comparator group

Description:

For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent 14 consecutive daily sessions of sham-taVNS (the electrodes were fixed at the the left earlobe).

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation (sham）