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

Nanjing Medical University

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Device: Transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05561348

2022-SR-535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

active transcutaneous auricular vagus nerve stimulation

Experimental group

Description:

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

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation

sham transcutaneous auricular vagus nerve stimulation

Sham Comparator group

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).

Treatment:

Device: Transcutaneous auricular vagus nerve stimulation