Back to resultsThe Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcutaneous auricular vagus nerve stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring gait, Therapeutics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- the First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
active transcutaneous auricular vagus nerve stimulation
sham transcutaneous auricular vagus nerve stimulation
Arm Description
For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS.
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).
Outcomes
Primary Outcome Measures
Change from Baseline Velocity at one day post intervention
The velocity will be recorded in cm/s.
Change from Baseline Step length at one day post intervention
The step length will be recorded in meters.
Change from Baseline arm ROM maximum at 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
The turning average duration velocity will be recorded in cm/s.
Change from Baseline gait cycle at 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
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms.
Changes in Tinetti Gait scores at one day post intervention
This indicator mainly reflects the stability of posture .
Changes in Tinetti Balance scores at one day post intervention
This indicator mainly reflects the stability of gait.
Secondary Outcome Measures
Changes in ΔHbO2 concentration in the brain cortex
The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
Full Information
NCT ID
NCT05561348
First Posted
September 22, 2022
Last Updated
October 14, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05561348
Brief Title
The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD
Official Title
Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
gait, Therapeutics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active transcutaneous auricular vagus nerve stimulation
Arm Type
Experimental
Arm Description
For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS.
Arm Title
sham transcutaneous auricular vagus nerve stimulation
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcutaneous auricular vagus nerve stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Velocity at one day post intervention
Description
The velocity will be recorded in cm/s.
Time Frame
Assessed at baseline, one day post intervention
Title
Change from Baseline Step length at one day post intervention
Description
The step length will be recorded in meters.
Time Frame
Assessed at baseline, one day post intervention.
Title
Change from Baseline arm ROM maximum at one day post intervention
Description
The arm ROM maximum will be recorded in degree.
Time Frame
Assessed at baseline, one day post intervention.
Title
Change from Baseline turning average duration velocity at one day post intervention
Description
The turning average duration velocity will be recorded in cm/s.
Time Frame
Assessed at baseline, one day post intervention.
Title
Change from Baseline gait cycle at one day post intervention
Description
The gait cycle will be recorded in s.
Time Frame
Assessed at baseline, one day post intervention.
Title
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
Description
The measure mainly reflects the overall severity of Parkinson's disease motor symptoms.
Time Frame
Assessed at baseline, one day post intervention.
Title
Changes in Tinetti Gait scores at one day post intervention
Description
This indicator mainly reflects the stability of posture .
Time Frame
Assessed at baseline, one day post intervention.
Title
Changes in Tinetti Balance scores at one day post intervention
Description
This indicator mainly reflects the stability of gait.
Time Frame
Assessed at baseline, one day post intervention.
Secondary Outcome Measure Information:
Title
Changes in ΔHbO2 concentration in the brain cortex
Description
The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.
Time Frame
Assessed at baseline, one day post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Kezhong
Phone
13770840575
Email
kezhong_zhang1969@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Kezhong
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiang Su
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kezhong Zhang
Phone
13770840575
Email
kezhong_zhang1969@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD
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