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

NCT06665113 | Recruiting DMC

• 1 other identifier: 2024-SR-1019
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease, Idiopathic

Keywords

Parkinson Disease, Idiopathic; Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• MDS-UPDRS-Ⅲ

  Used to evaluate the motor function.

  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.

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

Secondary Outcomes (3)

• Scales: MDS-UPDRS-II

  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

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

• Scales: H&Y stage

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

Other Outcomes (18)

• Eye-Tracking Technology

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

• Electroencephalogram (EEG)

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

• MRI

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

Study Arms (2)

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

EXPERIMENTAL

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

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

SHAM COMPARATOR

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

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.

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

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.

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

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Receiving standard anti-Parkinson's disease medication treatment.

You may not qualify if:

• 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.
• 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.
• 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.
• 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.
• Previous history of stroke or intracranial mass lesions.
• Patients with existing or potential cardiovascular diseases.
• Ophthalmic diseases affecting eye movements.
• 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).
• Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.
• Concurrent participation in other clinical trials.
• Inability to receive the required treatment and follow-up due to geographic reasons.
• Any subject with an upper limb UPDRS tremor score of 3 or higher.

Sponsors & Collaborators

• Kezhong Zhang: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 211200, 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

• Kezhong Zhang, Professor

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kezhong Zhang, Professor

CONTACT

400-13770840575; kezhong_zhang1969@126.com

Study Design

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

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 30, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)