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The effect of bilateral percutaneous auricular vagus nerve stimulation on upper limb motor function in stroke patients and the exploration of brain remodeling mechanism

The effect of bilateral percutaneous auricular vagus nerve stimulation on upper limb motor function in stroke patients and the exploration of brain remodeling mechanism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120892
Enrollment
Unknown
Registered
2026-03-22
Start date
2026-03-30
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper limb dysfunction in stroke

Interventions

Bilateral Group (Bilateral Vagus Nerve Stimulation Group):30-minute bilateral vagus nerve stimulation before task-oriented training (Bilateral Vagus Nerve Stimulation Group)
electrodes placed at the cavum conchae and cavum antitragus
stimulation parameters: 0.3ms square pulse, 20Hz frequency, 30 seconds duration, repeated once per minute
current intensity set to patients maximum tolerable level
once daily, five times per week for four weeks.
Unilateral Group (Unilateral Vagus Nerve Stimulation Group):30-minute unilateral vagus nerve stimulation before task-oriented training (Unilateral Vagus Nerve Stimulation Group)
electrode placed on the left ear (cavum conchae)
Sham Stimulation Group (Control Group):Place electrodes (at both cavum conchae and cavum antitragus) and perform sham stimulation without electrical output

Sponsors

Shandong Second Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 80; 2. Stroke is diagnosed by a clinical doctor in accordance with the guidelines of the "Chinese Stroke Prevention and Treatment Guidelines"; 3. The first occurrence of ischemic or hemorrhagic stroke, with a course of more than 2 weeks but less than 1 year, and stable vital signs; 4. Unilateral hemiplegia of the upper limb, Brunnstrom stage III or above; 5. Have the ability to give informed consent and understand instructions.

Exclusion criteria

Exclusion criteria: 1. Having implanted devices such as a cardiac pacemaker; 2. Presence of abnormal skin conditions that may interfere with stimulation or the stimulation device, such as scar tissue or damaged skin; 3. Previous vagus nerve injury; 4. Upper limb dysfunction caused by reasons other than stroke; 5. Severe heart dysfunction or heart disease; 6. Injection of botulinum toxin within the past 3 months; 7. Use of antidepressants or benzodiazepines.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Upper Extremity Scale;Concentration of cerebral oxygenated hemoglobin;

Secondary

MeasureTime frame
Modified Ashworth scale;Box and Block Test;Hospital anxiety and depression scale;Grip strength and pinch strength test;

Countries

China

Contacts

Public ContactLiu Hao

Shandong Second Medical University

liuhao0909@163.com+86 139 6150 6516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026