NCT05950347

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 10, 2023

Last Update Submit

July 26, 2023

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseAnxietytaVNS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • change of HbO2 in the prefrontal cortex

    Assessed at baseline, one day post intervention

  • change of Unified Parkinson's Disease Rating Scale Score section III

    Assessed at baseline, one day post intervention，2 weeks post intervention

  • change of Unified Parkinson's Disease Rating Scale Score section I

    Assessed at baseline, one day post intervention，2 weeks post intervention

Study Arms (2)

Active Transcutaneous auricular vagus nerve stimulation

ACTIVE COMPARATOR

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

Sham Transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

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

Interventions

Active Transcutaneous auricular vagus nerve stimulationDEVICE

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.

Active Transcutaneous auricular vagus nerve stimulation
Sham Transcutaneous auricular vagus nerve stimulationDEVICE

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 Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Conditions

Parkinson DiseaseAnxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesMental Disorders

Central Study Contacts

Zhang Kezhong

CONTACT

13770840575kezhong_zhang1969@126.com

Zhang Kezhong, Study Principal Investigator

CONTACT

13770840575kezhong_zhang1969@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor，Chief physician

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

August 1, 2023

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

CN(1)