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

NCT05561348 | Unknown DMC

• 1 other identifier: 2022-SR-535
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

gait; Therapeutics

Outcome Measures

Primary Outcomes (8)

• Change from Baseline Velocity at one day post intervention

  The velocity will be recorded in cm/s.

  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.

  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.

  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.

  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.

  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.

  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 .

  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.

  Assessed at baseline, one day post intervention.

Secondary Outcomes (1)

• Changes in ΔHbO2 concentration in the brain cortex

  Assessed at baseline, one day post intervention.

Study Arms (2)

active transcutaneous auricular vagus nerve stimulation

EXPERIMENTAL

For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS.

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).

Device: Transcutaneous auricular vagus nerve stimulation

Interventions

Transcutaneous auricular vagus nerve stimulation DEVICE

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.

active transcutaneous auricular vagus nerve stimulation; sham transcutaneous auricular vagus nerve stimulation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Zhang Kezhong

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang Kezhong

CONTACT

13770840575; kezhong_zhang1969@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor，Chief physician

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: August 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: January 31, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)