Parkinson DiseaseNCT06409338
Research on the Brain Mechanism of taVNS in Regulating PD Motor Symptoms
A study testing Transcutaneous auricular vagus nerve stimulation (active） in people with Parkinson Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcutaneous auricular vagus nerve stimulation (active）
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Kezhong Zhang, 13770840575, kezhong_zhang1969@126.com
About this study
Official title: Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
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.
Read the detailed description
Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.
- Conditions
- Parkinson Disease
- Being tested
- Transcutaneous auricular vagus nerve stimulation (active）, Transcutaneous auricular vagus nerve stimulation (sham）
- Keywords
- Parkinson's disease, motor symptoms, taVNS, neural mechanism
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Transcutaneous auricular vagus nerve stimulation (sham） |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. UPDRS III is a motor examination score that includes 14 items such as facial expression, tremor, rigidity, motor delay, posture disorders, and gait examination, with a total score of 0-56 points. The higher the score, the more severe the physical movement symptoms are.
Measured: Assessed at baseline, one day post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start11 May 2024
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhang Kezhong, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409338
- Sponsor's protocol ID
- 2024-SR-235
- Status last verified
- Jun 2024
- First submitted
- 5 May 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Brain Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation in Regulating PD Motor Symptoms
- ClinicalTrials.gov ID
- NCT06409338
- Acronym / sponsor ID
- 2024-SR-235
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, motor symptoms, taVNS, neural mechanism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 11 May 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 May 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 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.
Detailed description
Patients in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS with the electrodes were fixed at the left earlobe . Assessments of motor symptoms and cortical activity (using Functional near-infrared spectroscopy and Transcranial magnetic stimulation) were performed two times: at baseline, one day post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Transcutaneous auricular vagus nerve stimulation | Active comparator | Device: Transcutaneous auricular vagus nerve stimulation (active）For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 14 consecutive daily sessions of taVNS. |
| Sham Transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Transcutaneous auricular vagus nerve stimulation (sham）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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (6 listed)
- (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;
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 |
|---|---|---|
| Transcutaneous auricular vagus nerve stimulation (active）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. | Device | Active Transcutaneous auricular vagus nerve stimulation |
| Transcutaneous auricular vagus nerve stimulation (sham）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. | Device | Sham Transcutaneous auricular vagus nerve stimulation |
Primary outcome
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma
Time frame: Assessed at baseline, one day post intervention
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.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-global efficiency (Eg)
Time frame: Assessed at baseline, one day post intervention
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.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-local efficiency (Eloc)
Time frame: Assessed at baseline, one day post intervention
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.
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-nodal efficiency (Ne)
Time frame: Assessed at baseline, one day post intervention
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.
changes in MEPs values
Time frame: Assessed at baseline, one day post intervention
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).
changes in RMT values
Time frame: Assessed at baseline, one day post intervention
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.
changes in CSP values
Time frame: Assessed at baseline, one day post intervention
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.
changes in SICI values
Time frame: Assessed at baseline, one day post intervention
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.
changes in ICF values
Time frame: Assessed at baseline, one day post intervention
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.
1 secondary outcome
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
Time frame: Assessed at baseline, one day post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Zhang Kezhong 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 Transcutaneous auricular vagus nerve stimulation (active） in people with Parkinson Disease, run by The First Affiliated Hospital with Nanjing Medical University 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 6 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang Kezhong (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?
alterations in functional topological properties within the cortex of bilateral cerebral hemispheres-Sigma (time frame: Assessed at baseline, one day post intervention). The study lists 9 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 3 Jul 2024.