Parkinson Disease, IdiopathicNLTVNSPDNCT06665113
Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients
A study testing taVNS real stimulation in people with Parkinson Disease, Idiopathic, run by Kezhong Zhang at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- taVNS real stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Patients with a history of PD-related freezing episodes or falls.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 211200
Kezhong Zhang, 13770840575, kezhong_zhang1969@126.com
About this study
Official title: A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients
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.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- taVNS real stimulation, taVNS sham stimulation
- Keywords
- Parkinson Disease, Idiopathic, Vagus Nerve Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNS real stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: taVNS sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS-Ⅲ
Used to evaluate the motor function.
Measured: 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.
Measured: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days
Secondary outcomes (3)
Scales: MDS-UPDRS-II
Used to evaluate quality of life of PD.
Measured: 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
Measured: baseline,180±7 days, 360±7 days, 540±7 days，570±7 days
Scales: H&Y stage
Used to evaluate the stage of PD.
Measured: baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start23 Dec 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kezhong Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kezhong Zhang, Professor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665113
- Sponsor's protocol ID
- 2024-SR-1019
- Acronym
- NLTVNSPD
- Status last verified
- Jan 2025
- First submitted
- 20 Oct 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients
- ClinicalTrials.gov ID
- NCT06665113
- Acronym / sponsor ID
- NLTVNSPD / 2024-SR-1019
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Parkinson Disease, Idiopathic, Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kezhong ZhangUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard anti-Parkinson's disease medication treatment + taVNS real stimulation | Experimental | Device: taVNS real stimulationFor 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. |
| Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation | Sham comparator | Device: taVNS sham stimulationFor 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNS real stimulationFor 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. | Device | Standard anti-Parkinson's disease medication treatment + taVNS real stimulation |
| taVNS sham stimulationFor 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. | Device | Standard anti-Parkinson's disease medication treatment + taVNS sham stimulation |
Primary outcome
MDS-UPDRS-Ⅲ
Time frame: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days
Used to evaluate the motor function.
Free water in the posterior substantia nigra (DTI)
Time frame: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days
Used to measure progression of early Parkinson's disease.
3 secondary outcomes
Scales: MDS-UPDRS-II
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
Time frame: baseline,180±7 days, 360±7 days, 540±7 days，570±7 days
Scales: H&Y stage
Time frame: baseline,30±3 days,90±5 days,180±7 days, 360±7 days, 540±7 days，570±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease, Idiopathic
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
Recruiting
MediPD: An Online Mediterranean Diet Program for People Living With Parkinson's Disease
Parkinson Disease, Idiopathic
Recruiting
Ginger-PD: Ginger as a Modifier of Ghrelin Levels and Gut Function in Parkinson's Disease
REM Sleep Behavior Disorder, Parkinson s Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kezhong Zhang, Professor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS real stimulation in people with Parkinson Disease, Idiopathic, run by Kezhong Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kezhong Zhang, Professor (400-13770840575, kezhong_zhang1969@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS-Ⅲ (time frame: baseline, 180±7 days, 360±7 days, 540±7 days，570±7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.