Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
NCT ID: NCT06827301
Last Updated: 2025-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-11-23
2026-06-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Real t-VNS
real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
Non Invasive vagus nerve stimulation
Transcutaneous Auricular Vagus Nerve Stimulation
Sham t-VNS
sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.
Non Invasive vagus nerve stimulation
Transcutaneous Auricular Vagus Nerve Stimulation
Interventions
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Non Invasive vagus nerve stimulation
Transcutaneous Auricular Vagus Nerve Stimulation
Eligibility Criteria
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Inclusion Criteria
* Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5
Exclusion Criteria
* Dementia or other medical conditions that may interfere with the study
18 Years
ALL
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Di Lazzaro Vincenzo
Prof
Locations
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Università Campus Bio-Medico di Roma
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LOGIC
Identifier Type: -
Identifier Source: org_study_id
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