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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06409338
• Other study ID #: 2024-SR-235
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zhang Kezhong
• Phone: 13770840575
• Email: kezhong_zhang1969[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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 month;

• (6) with concomitant severe neurologic, renal, cardiovascular, or hepatic disease.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma	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
Primary	alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)	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
Primary	alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-local efficiency (Eloc)	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
Primary	alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-nodal efficiency (Ne)	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
Primary	changes in MEPs values	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
Primary	changes in RMT values	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
Primary	changes in CSP values	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
Primary	changes in SICI values	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
Primary	changes in ICF values	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	Change from Baseline Unified Parkinson's Disease Rating Scale-III at 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