Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06827301

Acronym

LOGIC

Enrollment

Registered

2025-02-14

Start date

2024-11-23

Completion date

2026-06-30

Last updated

2025-02-14

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

Conditions

Dysphagia Following Cerebrovascular Accident

Keywords

vagus nerve stimulation, dysphagia, stroke

Brief summary

The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition. 30 patients will be randomized into one of the two arms of the study: * REAL: real t-VNS + speech therapy * SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear. Swallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).

Interventions

DEVICENon Invasive vagus nerve stimulation

Transcutaneous Auricular Vagus Nerve Stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Acute ischemic or hemorrhagic stroke (within 7 days of onset) * Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5

Exclusion criteria

* Pre-existing stroke dysphagia * Dementia or other medical conditions that may interfere with the study

Design outcomes

Primary

Measure	Time frame	Description
Swallowing function	Baseline, Immediately after intervention	Swallowing video fluoroscopic will be used to measure swallowing function

Secondary

Measure	Time frame	Description
Disability	Baseline, Immediately after intervention, 3 months after intervention	Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.
Mortality	Baseline, Immediately after intervention, 3 months after intervention	Number of deaths
Morbidity	Baseline, Immediately after intervention, 3 months after intervention	Number of aspiration pneumonia
Swallowing function	Baseline, 3 months after intervention	Swallowing video fluoroscopic will be used to measure swallowing function

Countries

Italy

Contacts

Primary ContactFioravante Capone, PhD

f.capone@policlinicocampus.it06225411220

Backup ContactFabio Pilato, MD

f.pilato@policlinicocampus.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026