Clinical trial NCT06409338: Research on the Brain Mechanism of taVNS in Regulating PD Motor Symptoms
Official title: Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
motor symptoms
taVNS
neural mechanism
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma
timeFrame: Assessed at baseline, one day post intervention
measure: alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)
timeFrame: Assessed at baseline, one day post intervention
measure: alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-local efficiency (Eloc)
timeFrame: Assessed at baseline, one day post intervention
measure: alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-nodal efficiency (Ne)
timeFrame: Assessed at baseline, one day post intervention
measure: changes in MEPs values
timeFrame: Assessed at baseline, one day post intervention
measure: changes in RMT values
timeFrame: Assessed at baseline, one day post intervention
measure: changes in CSP values
timeFrame: Assessed at baseline, one day post intervention
measure: changes in SICI values
timeFrame: Assessed at baseline, one day post intervention
measure: changes in ICF values
timeFrame: Assessed at baseline, one day post intervention
Secondary outcomes:
measure: Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiang Su
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhang Kezhong
role: PRINCIPAL_INVESTIGATOR
References: