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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-11

Study Completion Date

2024-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Transcutaneous auricular vagus nerve stimulation

For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 14 consecutive daily sessions of taVNS.

Group Type ACTIVE_COMPARATOR

Transcutaneous auricular vagus nerve stimulation (active）

Intervention Type DEVICE

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 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).

Group Type SHAM_COMPARATOR

Transcutaneous auricular vagus nerve stimulation (sham）

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes