Clinical trial NCT05561348: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: gait
Therapeutics
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline Velocity at one day post intervention
timeFrame: Assessed at baseline, one day post intervention
measure: Change from Baseline Step length at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Change from Baseline arm ROM maximum at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Change from Baseline turning average duration velocity at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Change from Baseline gait cycle at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Changes in Tinetti Gait scores at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
measure: Changes in Tinetti Balance scores at one day post intervention
timeFrame: Assessed at baseline, one day post intervention.
Secondary outcomes:
measure: Changes in ΔHbO2 concentration in the brain cortex
timeFrame: Assessed at baseline, one day post intervention.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiang Su
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhang Kezhong
role: PRINCIPAL_INVESTIGATOR
References: