Actively Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
Led by Campus Bio-Medico University · Updated on 2025-02-14
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating transcutaneous auricular vagus nerve stimulation (t-VNS) combined with speech therapy to treat swallowing difficulties (dysphagia) in patients who recently had a stroke. The goal is to improve swallowing function and reduce related disability and mortality. This interventional study randomly assigns 30 acute stroke patients to receive either real t-VNS or a placebo version alongside speech therapy. Participants receive treatment on the left ear with either real or sham t-VNS for 40 minutes daily during speech therapy sessions, repeated for three consecutive days. The study compares the effects of the real stimulation plus speech therapy against placebo stimulation plus speech therapy to assess improvements in swallowing and clinical outcomes. Swallowing ability and clinical status are assessed at three points: before treatment, immediately after the intervention, and three months later. Researchers measure swallowing function as the primary outcome and also examine disability, mortality, and morbidity at these times to monitor long-term effects. Participants are observed over this period to evaluate the therapy's impact on recovery after stroke.
CONDITIONS
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute ischemic or hemorrhagic stroke within 7 days of onset
- Dysphagia diagnosed by fiberoptic endoscopic evaluation with a severity score between 3 and 5
- Adults aged 18 years or older
You will not qualify if you...
- Pre-existing stroke-related swallowing difficulties
- Dementia or other medical conditions that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days from stroke onset
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants receive transcutaneous auricular vagus nerve stimulation on the left ear for 40 minutes daily for 3 consecutive days, simultaneously with speech therapy.
3 daily visits (in-person)
Trial Site Locations
Total: 1 location
1
Università Campus Bio-Medico di Roma
Roma, RM, Italy, 00128
Actively Recruiting
Research Team
F
Fioravante Capone, PhD
F
Fabio Pilato, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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