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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

32

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • 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)

May 11, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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