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

Not Applicable

Recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Transcutaneous auricular vagus nerve stimulation

• Registration Number: NCT05561348
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-30
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18
• Primary Completion: 2022-12-30
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
active transcutaneous auricular vagus nerve stimulation	Transcutaneous auricular vagus nerve stimulation	For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS.
sham transcutaneous auricular vagus nerve stimulation	Transcutaneous auricular vagus nerve stimulation	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).

Primary Outcome Measures

Name	Time	Method
Change from Baseline gait cycle at one day post intervention	Assessed at baseline, one day post intervention.	The gait cycle will be recorded in s.
Changes in Tinetti Gait scores at one day post intervention	Assessed at baseline, one day post intervention.	This indicator mainly reflects the stability of posture .
Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention	Assessed at baseline, one day post intervention.	The measure mainly reflects the overall severity of Parkinson's disease motor symptoms.
Change from Baseline arm ROM maximum at one day post intervention	Assessed at baseline, one day post intervention.	The arm ROM maximum will be recorded in degree.
Changes in Tinetti Balance scores at one day post intervention	Assessed at baseline, one day post intervention.	This indicator mainly reflects the stability of gait.
Change from Baseline Velocity at one day post intervention	Assessed at baseline, one day post intervention	The velocity will be recorded in cm/s.
Change from Baseline turning average duration velocity at one day post intervention	Assessed at baseline, one day post intervention.	The turning average duration velocity will be recorded in cm/s.
Change from Baseline Step length at one day post intervention	Assessed at baseline, one day post intervention.	The step length will be recorded in meters.

Secondary Outcome Measures

Name	Time	Method
Changes in ΔHbO2 concentration in the brain cortex	Assessed at baseline, one day post intervention.	The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin.

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiang Su, China