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

The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in Parkinson's Disease

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.

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.

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.