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

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ClinicalTrials.gov Identifier: NCT05950347
Recruitment Status : Not yet recruiting
First Posted : July 18, 2023
Last Update Posted : July 28, 2023
Sponsor:
Information provided by (Responsible Party):
Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Active Transcutaneous auricular vagus nerve stimulation Device: Sham Transcutaneous auricular vagus nerve stimulation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Anxiety in Parkinson's Disease
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Transcutaneous auricular vagus nerve stimulation
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.
 Device: Active Transcutaneous auricular vagus nerve stimulation
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.
Sham Comparator: Sham Transcutaneous auricular vagus nerve stimulation
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.
 Device: Sham Transcutaneous auricular vagus nerve stimulation
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.


Outcome Measures
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Primary Outcome Measures :
  1. change of Hamilton Anxiety Scale Score [ Time Frame: Assessed at baseline, one day post intervention，2 weeks post intervention ]
    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.


Secondary Outcome Measures :
  1. change of HbO2 in the prefrontal cortex [ Time Frame: Assessed at baseline, one day post intervention ]
    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.

  2. change of Unified Parkinson's Disease Rating Scale Score section III [ Time Frame: Assessed at baseline, one day post intervention，2 weeks post intervention ]
    Unified Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms.

  3. change of Unified Parkinson's Disease Rating Scale Score section I [ Time Frame: Assessed at baseline, one day post intervention，2 weeks post intervention ]
    Unified Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions)


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05950347


Contacts
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Contact: Zhang Kezhong 13770840575 kezhong_zhang1969@126.com
Contact: Zhang Kezhong, Study Principal Investigator 13770840575 kezhong_zhang1969@126.com

Locations
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China, Jiang Su
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiang Su, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
More Information
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Responsible Party: Kezhong Zhang, professor，Chief physician, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT05950347    
Other Study ID Numbers: 2023-07
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: July 28, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University:
Parkinson's disease
Anxiety
taVNS
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases