Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia (LOGIC)

Campus Bio-Medico University of Rome

Status: Enrolling

Conditions: Dysphagia Following Cerebrovascular Accident

Treatments: Device: Non Invasive vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06827301

LOGIC

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 2 patient groups

Real t-VNS

Experimental group

Description:

real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.

Treatment:

Device: Non Invasive vagus nerve stimulation

Sham t-VNS

Active Comparator group

Description:

sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.

Treatment:

Device: Non Invasive vagus nerve stimulation