Health TrialsbyHealthPanel

Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

ConditionDysphagia Following Cerebrovascular Accident
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCampus Bio-Medico University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-existing stroke dysphagia

Dementia or other medical conditions that may interfere with the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non Invasive vagus nerve stimulation

    Device

    Transcutaneous Auricular Vagus Nerve Stimulation

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Real t-VNSExperimental treatment 1 intervention
Group B: Sham t-VNSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Swallowing function

Swallowing video fluoroscopic will be used to measure swallowing function

Time frame
Baseline, Immediately after intervention

Secondary outcomes

1

Disability

Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.

Time frame
Baseline, Immediately after intervention, 3 months after intervention
2

Mortality

Number of deaths

Time frame
Baseline, Immediately after intervention, 3 months after intervention
3

Morbidity

Number of aspiration pneumonia

Time frame
Baseline, Immediately after intervention, 3 months after intervention
4

Swallowing function

Swallowing video fluoroscopic will be used to measure swallowing function

Time frame
Baseline, 3 months after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Campus Bio-Medico University

Lead sponsor

Source ClinicalTrials.gov
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