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

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Active Transcutaneous auricular vagus nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Anxiety, taVNS

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

the First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Transcutaneous auricular vagus nerve stimulation

Sham Transcutaneous auricular vagus nerve stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Uniﬁed Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms.

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

Uniﬁed Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions)

Full Information

NCT ID

NCT05950347

First Posted

July 10, 2023

Last Updated

July 26, 2023

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05950347

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2023 (Anticipated)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson's disease, Anxiety, taVNS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Transcutaneous auricular vagus nerve stimulation

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Sham Transcutaneous auricular vagus nerve stimulation

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Active Transcutaneous auricular vagus nerve stimulation

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham Transcutaneous auricular vagus nerve stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

change of Hamilton Anxiety Scale Score

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

change of HbO2 in the prefrontal cortex

Description

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.

Time Frame

Assessed at baseline, one day post intervention

Title

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

Description

Uniﬁed Parkinson's Disease Rating Scale Score section III were used to assess the severity of motor symptoms.

Time Frame

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

Title

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

Description

Uniﬁed Parkinson's Disease Rating Scale Score section I can evaluate changes in mental state and cognition (including behavior and emotions)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Kezhong

Phone

13770840575

Email

kezhong_zhang1969@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Kezhong, Study Principal Investigator

Phone

13770840575

Email

kezhong_zhang1969@126.com

Facility Information:

Facility Name

the First Affiliated Hospital of Nanjing Medical University

City

Nanjing

State/Province

Jiang Su

ZIP/Postal Code

210029

Country

China

Parkinson Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial