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

NCT06409338 | Recruiting

• 1 other identifier: 2024-SR-235
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; motor symptoms; taVNS; neural mechanism

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention

  Assessed at baseline, one day post intervention

Study Arms (2)

Active Transcutaneous auricular vagus nerve stimulation

ACTIVE COMPARATOR

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

Device: Transcutaneous auricular vagus nerve stimulation (active）

Sham Transcutaneous auricular vagus nerve stimulation

SHAM COMPARATOR

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）

Interventions

Transcutaneous auricular vagus nerve stimulation (active） 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.

Active Transcutaneous auricular vagus nerve stimulation

Transcutaneous auricular vagus nerve stimulation (sham） 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.

Sham Transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Zhang Kezhong

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Kezhong

CONTACT

13770840575; kezhong_zhang1969@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 10, 2024
• Study Start: May 11, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)