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RecruitingNCT06665113NLTVNSPDUpdated Jan 14, 2025

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

An interventional study of taVNS real stimulation and taVNS sham stimulation in Parkinson Disease, Idiopathic, sponsored by Kezhong Zhang. Recruiting at 1 site in China. Open to participants aged 55 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by Kezhong Zhang · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study summary

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.

Read the detailed description

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, , aiming to investigate a novel therapeutic approach for delaying PD progression.

02

Conditions studied

  • Parkinson Disease, Idiopathic

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Keywords

  • Parkinson Disease, Idiopathic
  • Vagus Nerve Stimulation
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 12 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Kezhong Zhang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 55-75 years.
  2. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.
  3. Hoehn and Yahr (H\&Y) stage ≤ 2.5 at medication initiation.
  4. Parkinson's disease duration ≤ 3 years.
  5. Receiving standard anti-Parkinson's disease medication treatment.

Exclusion criteria

Exclusion Criteria:

  1. Patients with cognitive impairment (MMSE \< 24 and/or MoCA \< 26) or mental illnesses, or those unable to cooperate for other reasons.
  2. 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.
  3. 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.
  4. Previous treatment with vagus nerve stimulation.
  5. MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts > 1 cm³ or > 3 lacunar infarcts.
  6. Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation.
  7. Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related.
  8. Previous history of stroke or intracranial mass lesions.
  9. Patients with existing or potential cardiovascular diseases.
  10. Ophthalmic diseases affecting eye movements.
  11. Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae).
  12. Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.
  13. Concurrent participation in other clinical trials.
  14. Inability to receive the required treatment and follow-up due to geographic reasons.
  15. Any subject with an upper limb UPDRS tremor score of 3 or higher.
  16. Patients with a history of PD-related freezing episodes or falls.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Standard anti-Parkinson's disease medication treatment + taVNS real stimulation

    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. Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.

    Device: taVNS real stimulation

  • Sham comparator
    Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation

    For the sham stimulation group, two modified point electrodes will deliver stimulation to the earlobes.Each Parkinson's disease patient will receive one 30-minute stimulation session per day(at least 5 days per week) for 270 consecutive days.

    Device: taVNS sham stimulation

Interventions

  • DevicetaVNS real stimulation

    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.

  • DevicetaVNS sham stimulation

    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.

06

What researchers measure

Primary outcomes

  1. MDS-UPDRS-Ⅲ

    Used to evaluate the motor function.

    Time frame: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days

  2. 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

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. Movement Disorder Society Unified Parkinson's Disease Rating Scale - Part I (MDS-UPDRS-I)

    .Measurement: Score (range: 0-52; higher score indicates worse non-motor function).

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

  6. Non-Motor Symptoms Scale (NMSS)

    Measurement: Score (range: 0-100; higher score indicates more severe non-motor symptoms).

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

  7. Activities of Daily Living (ADL) Scale

    Measurement: Score (range: 0-100; higher score indicates greater independence).

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

  8. Hamilton Anxiety Scale (HAMA)

    Measurement: Score (range: 0-56; higher score indicates greater anxiety).

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

  9. Hamilton Depression Rating Scale - 24 items (HAMD-24)

    Measurement: Score (range: 0-76; higher score indicates greater depression severity).

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

  10. Apathy Scale (AS)

    Measurement: Score (range: 0-42; higher score indicates greater apathy).

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

  11. Rapid Eye Movement Sleep Behavior Disorder Questionnaire (RBDSQ)

    Measurement: Score (range: 0-25; higher score indicates more severe symptoms).

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

  12. Epworth Sleepiness Scale (ESS)

    Measurement: Score (range: 0-24; higher score indicates greater daytime sleepiness).

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

  13. Montreal Cognitive Assessment (MoCA)

    Measurement: Score (range: 0-30; higher score indicates better cognitive function).

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

  14. Hopkins Verbal Learning Test - Revised (HVLT-R)

    Measurement: Score (varies by subscale; higher score indicates better verbal memory).

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

  15. Judgment of Line Orientation (JLO)

    Measurement: Score (range: 0-30; higher score indicates better visual-spatial abilities).

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

  16. Letter-Number Sequencing (LNS)

    Measurement: Score (range: 0-30; higher score indicates better working memory).

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

  17. Symbol Digit Modalities Test (SDMT)

    Measurement: Score (varies based on response time; higher score indicates faster processing speed).

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

  18. Levodopa Equivalent Dose (LED)

    Measurement: Dose (measured in mg; higher dose indicates greater medication requirement).

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

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu 211200, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06665113
Lead sponsor
Kezhong Zhang
Responsible party
Kezhong Zhang (Professor, The First Affiliated Hospital with Nanjing Medical University) — Sponsor-investigator
First posted
Oct 30, 2024
Start date
Dec 23, 2024
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jan 14, 2025

Study contacts

Kezhong Zhang, Professor
Contact
kezhong_zhang1969@126.com
400-13770840575
Kezhong Zhang, Professor
principal investigator · The First Affiliated Hospital with Nanjing Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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