The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in PD

Nanjing Medical University

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Active Transcutaneous auricular vagus nerve stimulation; Device: Sham Transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05950347

2023-07

Details and patient eligibility

About

This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with anxiety. The investigators hypothesize that taVNS will improve anxiety and cortical activity in Parkinson's disease patients with anxiety.

Full description

Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS. Assessments of anxiety symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention. The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post intervention.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• (1) diagnosed with idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD;
• (2) meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for anxiety and Hamilton Anxiety Scale (HAMA) score ≥ 12;
• (3) stable pharmacotherapy for PD at least one month prior to the study;
• (4) 40-80 years old;
• (5) willing to sign written informed consent.

Exclusion criteria

• (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) < 23;
• (2) took antianxiety drugs;
• (3) with taVNS contraindications;
• (4) received VNS treatment during the past month;
• (5) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active Transcutaneous auricular vagus nerve stimulation

Active Comparator group

Description:

Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds，repeat until 30 min. Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.

Treatment:

Device: Active Transcutaneous auricular vagus nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

Sham Comparator group

Description:

Two modified dot-like electrodes delivered the stimulation to the left earlobe. Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds，repeat until 30 min. Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days. The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.

Treatment:

Device: Sham Transcutaneous auricular vagus nerve stimulation