Research on the Brain Mechanism of taVNS in Regulating PD Motor Symptoms

June 30, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University

Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms

This study is a double blind comparative study exploring the neural underpinnings of taVNS modulating PD motor deficits. We hypothesize that taVNS might improve PD motor deficits by regulating the balance between excitation and inhibition in the primary motor cortex.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiang Su
      • Nanjing, Jiang Su, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1) had a diagnosis of idiopathic PD according to the Movement Disorder Society Clinical Diagnostic Criteria for PD and ON-medication Hoehn and Yahr (H&Y) stage ≤2,
  • (2) had stable pharmacotherapy for PD at least one month prior to the study,
  • (3) were aged between 40 and 80,
  • (4) signed written informed consent,
  • (5) can cooperate with the testing and taVNS treatment.

Exclusion Criteria:

  • (1) with cognitive impairment, according to Montreal Cognitive Assessment (MOCA) < 24;
  • (2) with severe tremor or levodopa-induced dyskinesia;
  • (3) with current intake of anticholinergics or any drugs that could induce cerebral functional change;
  • (4) with taVNS contraindications;
  • (5) received VNS treatment during the past six month;
  • (6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active Transcutaneous auricular vagus nerve stimulation
For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 14 consecutive daily sessions of taVNS.
Device: Transcutaneous auricular vagus nerve stimulation (active）
Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.
Sham Comparator: Sham Transcutaneous auricular vagus nerve stimulation
For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent 14 consecutive daily sessions of sham-taVNS (the electrodes were fixed at the the left earlobe).
Device: Transcutaneous auricular vagus nerve stimulation (sham）
In the sham stimulation group, the electrodes were fixed at the left earlobe with the same stimulus parameters. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma
Time Frame: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate three typical global parameters named small-worldness (Sigma) which can valuatable cortical network small world attributes.
Assessed at baseline, one day post intervention
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)
Time Frame: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate three typical global parameters named global efficiency (Eg) which can To evaluate the global efficiency of parallel information transmission in cortical networks.
Assessed at baseline, one day post intervention
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-local efficiency (Eloc)
Time Frame: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate typical global parameter named local efficiency (Eloc) which can evaluate functional separation in cortical networks.
Assessed at baseline, one day post intervention
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-nodal efficiency (Ne)
Time Frame: Assessed at baseline, one day post intervention
Resting state fNIRS data was preprocessed to obtain the cortical oxyhemoglobin values which indicate the cortical excitability. Based on the established cortical functional network, we calculate one nodal parameter named nodal efficiency (Ne) which can evaluate the nodal efficiency of information transmission in cortical networks.
Assessed at baseline, one day post intervention
changes in MEPs values
Time Frame: Assessed at baseline, one day post intervention
Surface electromyography (sEMG) recordings from the abductor pollicis brevis (APB) muscle were obtained to record motor evoked potentials (MEPs), which underwent amplification and filtering (bandwidth 20 Hz to 2000 Hz).
Assessed at baseline, one day post intervention
changes in RMT values
Time Frame: Assessed at baseline, one day post intervention
The individual resting motor threshold (RMT) was established as the minimum stimulus intensity required to evoke a MEP peak-to-peak amplitude of at least 0.05 mV in five of ten consecutive trials in a resting muscle.
Assessed at baseline, one day post intervention
changes in CSP values
Time Frame: Assessed at baseline, one day post intervention
The cortical silent period (CSP) was measured by sEMG of the APB following a single TMS pulse at 130% of the RMT to the opposite PMC-UL, while participants were requested to maintain active contraction of the APB at 20% of the maximum force.
Assessed at baseline, one day post intervention
changes in SICI values
Time Frame: Assessed at baseline, one day post intervention
Test stimulus intensity was set according to an unconditioned MEP with an amplitude of ~1 mV. For the conditioning stimulus of SICI and ICF, 80% of RMT was used. We tested interstimulus intervals (ISIs) of 2 and 4 ms for SICI. Each ISI was repeated 10 times to calculate the average value.
Assessed at baseline, one day post intervention
changes in ICF values
Time Frame: Assessed at baseline, one day post intervention
Test stimulus intensity was set according to an unconditioned MEP with an amplitude of ~1 mV. For the conditioning stimulus of SICI and ICF, 80% of RMT was used. We tested interstimulus intervals (ISIs) of 10 and 15 ms for ICF. Each ISI was repeated 10 times to calculate the average value.
Assessed at baseline, one day post intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
Time Frame: Assessed at baseline, one day post intervention
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. UPDRS III is a motor examination score that includes 14 items such as facial expression, tremor, rigidity, motor delay, posture disorders, and gait examination, with a total score of 0-56 points. The higher the score, the more severe the physical movement symptoms are.
Assessed at baseline, one day post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhang Kezhong, The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-SR-235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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