Parkinson DiseaseNCT05561348
The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD
A study testing Transcutaneous auricular vagus nerve stimulation 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 examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in… 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Jan 2023
- 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
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- Hoehn and Yahr stage ≤ 2 during ON medication state.
- Age between 40 and 80 years old.
- Mini-Mental State Examination score >24.
- Ability to walk at least 60s independently.
- Stable medication
Who cannot join
- Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study.
- Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded
- Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.
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: Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease
This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.
Read the detailed description
Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.
- Conditions
- Parkinson Disease
- Being tested
- Transcutaneous auricular vagus nerve stimulation
- Keywords
- gait, Therapeutics
- 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 stimulationDevice
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. In the sham stimulation group, the electrodes were fixed at the same position without releasing current.
| Study group | Role | What they receive |
|---|---|---|
| active transcutaneous auricular vagus nerve stimulation | Experimental | For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS. Receives: Device: Transcutaneous auricular vagus nerve stimulation |
| sham transcutaneous auricular vagus nerve stimulation | Sham comparator | For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent seven consecutive daily sessions of sham-taVNS (the electrodes were fixed at the same position without releasing current). Receives: Device: Transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Velocity at one day post intervention
The velocity will be recorded in cm/s.
Measured: Assessed at baseline, one day post intervention
Change from Baseline Step length at one day post intervention
The step length will be recorded in meters.
Measured: Assessed at baseline, one day post intervention.
Change from Baseline arm ROM maximum at one day post intervention
The arm ROM maximum will be recorded in degree.
Measured: Assessed at baseline, one day post intervention.
Change from Baseline turning average duration velocity at one day post intervention
The turning average duration velocity will be recorded in cm/s.
Measured: Assessed at baseline, one day post intervention.
Change from Baseline gait cycle at one day post intervention
The gait cycle will be recorded in s.
Measured: Assessed at baseline, one day post intervention.
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.
Measured: Assessed at baseline, one day post intervention.
Changes in Tinetti Gait scores at one day post intervention
This indicator mainly reflects the stability of posture .
Measured: Assessed at baseline, one day post intervention.
Changes in Tinetti Balance scores at one day post intervention
This indicator mainly reflects the stability of gait.
Measured: Assessed at baseline, one day post intervention.
Secondary outcomes (1)
Changes in ΔHbO2 concentration in the brain cortex
The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
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 posted30 Sep 2022
- Study start1 Aug 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Jan 2023 (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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kezhong Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Zhang Kezhong, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561348
- Sponsor's protocol ID
- 2022-SR-535
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05561348
- Acronym / sponsor ID
- 2022-SR-535
- Conditions
- Parkinson Disease
- Keywords
- gait, Therapeutics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 30 Sep 2022 (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 examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.
Detailed description
Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active transcutaneous auricular vagus nerve stimulation | Experimental | Device: Transcutaneous auricular vagus nerve stimulationFor Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS. |
| sham transcutaneous auricular vagus nerve stimulation | Sham comparator | Device: Transcutaneous auricular vagus nerve stimulationFor sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent seven consecutive daily sessions of sham-taVNS (the electrodes were fixed at the same position without releasing current). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.
- Hoehn and Yahr stage ≤ 2 during ON medication state.
- Age between 40 and 80 years old.
- Mini-Mental State Examination score >24.
- Ability to walk at least 60s independently.
Key exclusion criteria (3 listed)
- Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study.
- Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded
- Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.
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 stimulationTranscutaneous 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. In the sham stimulation group, the electrodes were fixed at the same position without releasing current. | Device | active transcutaneous auricular vagus nerve stimulation, sham transcutaneous auricular vagus nerve stimulation |
Primary outcome
Change from Baseline Velocity at one day post intervention
Time frame: Assessed at baseline, one day post intervention
The velocity will be recorded in cm/s.
Change from Baseline Step length at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
The step length will be recorded in meters.
Change from Baseline arm ROM maximum at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
The arm ROM maximum will be recorded in degree.
Change from Baseline turning average duration velocity at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
The turning average duration velocity will be recorded in cm/s.
Change from Baseline gait cycle at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
The gait cycle will be recorded in s.
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms.
Changes in Tinetti Gait scores at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
This indicator mainly reflects the stability of posture .
Changes in Tinetti Balance scores at one day post intervention
Time frame: Assessed at baseline, one day post intervention.
This indicator mainly reflects the stability of gait.
1 secondary outcome
Changes in ΔHbO2 concentration in the brain cortex
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 18 Oct 2022.
- 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 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 6 inclusion and 3 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 18 Oct 2022. 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?
Change from Baseline Velocity at one day post intervention (time frame: Assessed at baseline, one day post intervention). The study lists 8 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 18 Oct 2022.