Dysphagia Following Cerebrovascular AccidentLOGICNCT06827301
Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia
A study testing Non Invasive vagus nerve stimulation in people with Dysphagia Following Cerebrovascular Accident, run by Campus Bio-Medico University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia Following Cerebrovascular Accident
- What is being tested?
- Non Invasive vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pre-existing stroke dysphagia
- Dementia or other medical conditions that may interfere with the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fabio Pilato, MD contact
Italy1 site, 1 recruiting
- Recruiting
Università Campus Bio-Medico di Roma
Roma, RM, 00128
Vincenzo Di Lazzaro, +3906225411220, v.dilazzaro@unicampus.it
Fioravante Capone, PhD
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
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:
Read more
- 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).
- Being tested
- Non Invasive vagus nerve stimulation
- Keywords
- vagus nerve stimulation, dysphagia, stroke
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Invasive vagus nerve stimulationDevice
Transcutaneous Auricular Vagus Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Real t-VNS | Experimental | real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. Receives: Device: Non Invasive vagus nerve stimulation |
| Sham t-VNS | Active comparator | sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. Receives: Device: Non Invasive vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing function
Swallowing video fluoroscopic will be used to measure swallowing function
Measured: Baseline, Immediately after intervention
Secondary outcomes (4)
Disability
Disability will be measured by mRS and the necessity of nasogastric tube/gastrostomy.
Measured: Baseline, Immediately after intervention, 3 months after intervention
Mortality
Number of deaths
Measured: Baseline, Immediately after intervention, 3 months after intervention
Morbidity
Number of aspiration pneumonia
Measured: Baseline, Immediately after intervention, 3 months after intervention
Swallowing function
Swallowing video fluoroscopic will be used to measure swallowing function
Measured: Baseline, 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start23 Nov 2024
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysphagia Following Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827301
- Sponsor's protocol ID
- LOGIC
- Acronym
- LOGIC
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Capone F, Pilato F, Motolese F, Luccarelli V, Grattarola C, Selvaggi SA, Norata D, Rossi M, Todisco A, Celani LM, Marano M, Di Lazzaro V. Transcutaneous auricular vagus nerve stimulation for dysphagia in acute stroke: a randomized sham-controlled trial. Brain Stimul. 2026 Jul-Aug;19(4):103137. doi: 10.1016/j.brs.2026.103137. Epub 2026 Jun 2.
PubMed 42229578
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia
- ClinicalTrials.gov ID
- NCT06827301
- Acronym / sponsor ID
- LOGIC / LOGIC
- Keywords
- vagus nerve stimulation, dysphagia, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 23 Nov 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real t-VNS | Experimental | Device: Non Invasive vagus nerve stimulationreal t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. |
| Sham t-VNS | Active comparator | Device: Non Invasive vagus nerve stimulationsham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-existing stroke dysphagia
- Dementia or other medical conditions that may interfere with the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Invasive vagus nerve stimulationTranscutaneous Auricular Vagus Nerve Stimulation | Device | Real t-VNS, Sham t-VNS |
Primary outcome
Swallowing function
Time frame: Baseline, Immediately after intervention
Swallowing video fluoroscopic will be used to measure swallowing function
4 secondary outcomes
Disability
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Mortality
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Morbidity
Time frame: Baseline, Immediately after intervention, 3 months after intervention
Swallowing function
Time frame: Baseline, 3 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Derived from this study: PubMed 42229578Capone F, Pilato F, Motolese F, Luccarelli V, Grattarola C, Selvaggi SA, Norata D, Rossi M, Todisco A, Celani LM, Marano M, Di Lazzaro V. Transcutaneous auricular vagus nerve stimulation for dysphagia in acute stroke: a randomized sham-controlled trial. Brain Stimul. 2026 Jul-Aug;19(4):103137. doi: 10.1016/j.brs.2026.103137. Epub 2026 Jun 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio Pilato, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Invasive vagus nerve stimulation in people with Dysphagia Following Cerebrovascular Accident, run by Campus Bio-Medico University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fioravante Capone, PhD (06225411220, f.capone@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing function (time frame: Baseline, Immediately after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.