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Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia

Not Applicable
Recruiting
Conditions
Dysphagia Following Cerebrovascular Accident
Registration Number
NCT06827301
Lead Sponsor
Campus Bio-Medico University
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
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
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Swallowing functionBaseline, Immediately after intervention

Swallowing video fluoroscopic will be used to measure swallowing function

Secondary Outcome Measures
NameTimeMethod
DisabilityBaseline, Immediately after intervention, 3 months after intervention

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

Swallowing functionBaseline, 3 months after intervention

Swallowing video fluoroscopic will be used to measure swallowing function

MortalityBaseline, Immediately after intervention, 3 months after intervention

Number of deaths

MorbidityBaseline, Immediately after intervention, 3 months after intervention

Number of aspiration pneumonia

Trial Locations

Locations (1)

Università Campus Bio-Medico di Roma

🇮🇹

Roma, RM, Italy

Università Campus Bio-Medico di Roma
🇮🇹Roma, RM, Italy
Vincenzo Di Lazzaro
Contact
+3906225411220
v.dilazzaro@unicampus.it
Fioravante Capone, PhD
Contact
Fabio Pilato, MD
Contact
Vitaliana Luccarelli
Contact
Chiara Grattarola
Contact
Davide Norata, MD
Contact

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