Clinical trial NCT05950347: The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in PD
Official title: The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Anxiety
taVNS
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of Hamilton Anxiety Scale Score
timeFrame: Assessed at baseline, one day post intervention，2 weeks post intervention
Secondary outcomes:
measure: change of HbO2 in the prefrontal cortex
timeFrame: Assessed at baseline, one day post intervention
measure: change of Uniﬁed Parkinson's Disease Rating Scale Score section III
timeFrame: Assessed at baseline, one day post intervention，2 weeks post intervention
measure: change of Uniﬁed Parkinson's Disease Rating Scale Score section I
timeFrame: Assessed at baseline, one day post intervention，2 weeks post intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiang Su
Study officials:
References: