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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05950347
• Other study ID #: 2023-07
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zhang Kezhong
• Phone: 13770840575
• Email: kezhong_zhang1969[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Active Transcutaneous auricular vagus nerve stimulation
Two modi?ed 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.
• Sham Transcutaneous auricular vagus nerve stimulation
Two modi?ed 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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of Hamilton Anxiety Scale Score	Hamilton Anxiety Scale (HAM-A score), which was used for assessing the degree of anxiety. It consists of 14 symptomatic definition elements, with a total possible score of 56. The differences in HAMA score before and after treatment can be used to evaluate the effect of taVNS treatment.	Assessed at baseline, one day post intervention,2 weeks post intervention
Secondary	change of HbO2 in the prefrontal cortex	The change of HbO2 in the prefrontal cortex is accessed by fNIRS combined with verbal fluency task. Recent documents have highlighted the effectiveness of fNIRS combined with verbal fluency task (VFT) in detecting alterations in the PFC in patients with anxiety. The differences in HbO2 before and after treatment can be used to evaluate the effect of taVNS treatment.	Assessed at baseline, one day post intervention
Secondary	change of Uni?ed Parkinson's Disease Rating Scale Score section III	Uni?ed Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms.	Assessed at baseline, one day post intervention,2 weeks post intervention
Secondary	change of Uni?ed Parkinson's Disease Rating Scale Score section I	Uni?ed Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions)	Assessed at baseline, one day post intervention,2 weeks post intervention