Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients

ConditionParkinson Disease, Idiopathic

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age55-75

SponsorKezhong Zhang

About this trial

This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 55-75 years.

Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.

Hoehn and Yahr (H&Y) stage ≤ 2.5 at medication initiation.

Parkinson's disease duration ≤ 3 years.

Disqualifiers

Patients with cognitive impairment (MMSE < 24 and/or MoCA < 26) or mental illnesses, or those unable to cooperate for other reasons.

Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01.

Use of any medications that may affect dopamine metabolism and/or dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.

Previous treatment with vagus nerve stimulation.

Trial design

Design model

Parallel

Treatments tested in this trial

taVNS real stimulation
Device
For the real stimulation group, two modified point electrodes will deliver stimulation near the auricular branch of the vagus nerve in the left concha cymba. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.
taVNS sham stimulation
Device
For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs; continuous stimulation for 60 seconds, followed by a 10-second off period, repeated for 30 minutes.

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Standard anti-Parkinson's disease medication treatment + taVNS real stimulationExperimental treatment 1 intervention

Group B: Standard anti-Parkinson's disease medication treatment + taVNS sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

MDS-UPDRS-Ⅲ

Used to evaluate the motor function.

Time frame

baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days

Free water in the posterior substantia nigra (DTI)

Used to measure progression of early Parkinson's disease.

Time frame

baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days

Secondary outcomes

Scales: MDS-UPDRS-II

Used to evaluate quality of life of PD.

Time frame

baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days

Step Length、Stride Length、Stride Velocity and Step Length Variability

Used to assess the patient's gait disturbances，including the Step Length、Stride Length、Stride Velocity and Step Length Variability

Time frame

baseline,180±7 days, 360±7 days, 540±7 days，570±7 days

Scales: H&Y stage

Used to evaluate the stage of PD.

Time frame

baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days

Other outcomes

Eye-Tracking Technology

Fixation Duration: The length of time the gaze remains on a single point. Saccade Velocity: The speed of eye movements between fixations. Scan Path: The trajectory of eye movements during visual exploration

Time frame

baseline,180±7 days, 360±7 days, 540±7 days，570±7 days

Electroencephalogram (EEG)

Measurement: Brain wave activity (measured in microvolts, µV).

Time frame

baseline,180±7 days, 360±7 days, 540±7 days，570±7 days

MRI

T1-weighted Imaging: Measurement: Structural brain volume (measured in cubic centimeters, cm³). BOLD fMRI: Measurement: Blood oxygen level-dependent signals (measured in percentage change). Diffusion Tensor Imaging (DTI): Fractional Anisotropy (FA): Measurement: FA values (unitless, scale from 0 to 1). Mean Diffusivity (MD): Measurement: MD values (measured in mm²/s). NM-MRI: Measurement: Neurochemical markers (unit as appropriate). Iron-sensitive MRI: Quantitative Susceptibility Mapping (QSM): Measurement: Susceptibility values (measured in parts per million, ppm). Susceptibility Weighted Imaging (SWI): Measurement: Signal intensity (unitless). R2\*: Measurement: Relaxation rate (measured in Hz).

Time frame

baseline,180±7 days, 360±7 days, 540±7 days，570±7 days

Number of participants with the following Serum biomarkers:

Brain-Derived Neurotrophic Factor (BDNF): Measurement: Concentration (measured in ng/mL). Glial Fibrillary Acidic Protein (GFAP): Measurement: Concentration (measured in ng/mL). Neurofilament Light Chain (NFL): Measurement: Concentration (measured in pg/mL). Tau Protein: Measurement: Concentration (measured in pg/mL). Tumor Necrosis Factor Alpha (TNF-α): Measurement: Concentration (measured in pg/mL). Interleukin-6 (IL-6): Measurement: Concentration (measured in pg/mL). Interleukin-1 Beta (IL-1β): Measurement: Concentration (measured in pg/mL).

Time frame

baseline,180±7 days, 360±7 days, 540±7 days，570±7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kezhong Zhang

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov

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