The Effect and Mechanism of Transcutaneous Auricular Vagus Nerve Stimulation on Gait Impairments in PD

Parkinson Disease Clinical Trial

Official title:

Study on the Therapeutic Effect and Brain Mechanism of Transcutaneous Vagal Nerve Stimulation on Gait Impairments in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561348
• Other study ID #: 2022-SR-535
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: September 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Zhang Kezhong
• Phone: 13770840575
• Email: kezhong_zhang1969[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Parkinson's disease patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist.

2. Hoehn and Yahr stage = 2 during ON medication state.

3. Age between 40 and 80 years old.

4. Mini-Mental State Examination score >24.

5. Ability to walk at least 60s independently.

6. Stable medication

Exclusion Criteria:

1. 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.

2. Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded

3. Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Transcutaneous auricular vagus nerve stimulation
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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiang Su

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Velocity at one day post intervention	The velocity will be recorded in cm/s.	Assessed at baseline, one day post intervention
Primary	Change from Baseline Step length at one day post intervention	The step length will be recorded in meters.	Assessed at baseline, one day post intervention.
Primary	Change from Baseline arm ROM maximum at one day post intervention	The arm ROM maximum will be recorded in degree.	Assessed at baseline, one day post intervention.
Primary	Change from Baseline turning average duration velocity at one day post intervention	The turning average duration velocity will be recorded in cm/s.	Assessed at baseline, one day post intervention.
Primary	Change from Baseline gait cycle at one day post intervention	The gait cycle will be recorded in s.	Assessed at baseline, one day post intervention.
Primary	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.	Assessed at baseline, one day post intervention.
Primary	Changes in Tinetti Gait scores at one day post intervention	This indicator mainly reflects the stability of posture .	Assessed at baseline, one day post intervention.
Primary	Changes in Tinetti Balance scores at one day post intervention	This indicator mainly reflects the stability of gait.	Assessed at baseline, one day post intervention.
Secondary	Changes in ?HbO2 concentration in the brain cortex	The ?HbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.	Assessed at baseline, one day post intervention.