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Stroke, AcuteTR-VENUSNCT03733431

Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study

A study testing Gammacore device in people with Stroke, Acute and Stroke, Ischemic, run by Turkish Stroke Research and Clinical Trials Network at 8 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute, Stroke, Ischemic, Stroke
What is being tested?
Gammacore device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
69 participants
Where
8 sitesTurkey (Türkiye)
Study dates
10 May 2019to 1 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

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

  • Male or female patients who are older than 18 years old who have been admitted to neurological intensive care or stroke units with ischemic or hemorrhagic stroke
  • Patients with symptom onset time within 6 hours or with unknown time of onset and no evidence of acute ischemia on fluid attenuation inversion recovery (FLAIR) imaging
  • Patients who have given written informed consent prior to undertaking any study-related procedure.

Who cannot join

  • Patients who have a pre-stroke disability ≥ 2 according to the modified Rankin Score
  • Patients who have a NIH Stroke Scale/Score (NIHSS) ≤ 4 or ≥30
  • Patients who have a NIHSS item 1a ≥2
  • Patients who have experienced early dramatic neurological improvement (NIHSS score improvement ≥8) prior to study randomization suggesting resolution of signs/symptoms of stroke
  • Patients with classical lacunar syndrome
  • Patients who have local infection, rash or space occupying lesion at the stimulation site
Show all 26Show fewer
  • Patients with a prior injury to the vagus nerve (cervical vagotomy)
  • Patients with conditions that make the positioning of the device not possible such as tonic head deviation or involuntary movements of the head and neck
  • Patients using medications that can interfere with central neurotransmitter mechanisms potentially involved in the central vagal pathway (complete list is provided below under concomitant medications)
  • Patients with known severe (>90% stenosis) bilateral carotid artery disease
  • Patients with known carotid hypersensitivity
  • Patients who had undergone bilateral carotid endarterectomy or neck surgery involving the region of carotid triangle
  • Patients who have low blood pressure (Baseline SBP≤100 mmHg or DBP≤60 mmHg)
  • Patients who have slow heart rate (Baseline HR≤60/min)
  • Patients who have high blood pressure (SBP>220 mmHg or DBP>130 mmHg) despite initial line of treatment
  • Patients who have been involved in any investigational study within the previous 90 days
  • Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
  • Pregnant women
  • Patients with severe hypoglycemia at admission (<60 mg/dl)
  • Patient experiencing seizures
  • Patients with baseline ECG showing first-degree AV block; second- or third-degree atrio-ventricular block with no pacemaker/ICD in place; or ventricular tachycardia/fibrillation
  • Patients with digitalis toxicity
  • Patients who are suspected to have an acute coronary syndrome after clinical evaluations (Clinical, ECG, or any related biomarker)
  • Patients who are scheduled to have an emergent carotid artery angioplasty stenting or endarterectomy
  • Patients implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
  • Patients implanted with metal cervical spine hardware or having a metallic implant near the GammaCore stimulation site.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Turkey (Türkiye)8 sites

  • Ankara University Faculty of Medicine

    Ankara

  • Gazi University Faculty Of Medicine

    Ankara

  • Hacettepe University Faculty of Medicine

    Ankara

  • Akdeniz University

    Antalya

  • Eskişehir Osmangazi Faculty of Medicine

    Eskişehir

  • Necmettin Erbakan University

    Konya

  • Selcuk University

    Konya

  • Ondokuz Mayıs University Faculty of Medicine

    Samsun

Other trials in Turkey (Türkiye)

About this study

This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.

Being tested
Gammacore device, Gammacore sham device
Keywords
vagal nerve stimulation
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gammacore deviceDevice

    Transcutaneous stimulation of vagus nerve with the device positioned below the mandibular angle, medial to the sternocleidomastoid muscle and lateral to the larynx.

  • Gammacore sham deviceDevice

    Sham device which does not deliver electrical stimulation, but instead, produces a buzzing sound will be placed along the lateral border of the sternocleidomastoid muscle in order to avoid mechanical stimulation of the vagus nerve in the carotid triangle.

Study groups in NCT03733431
Study groupRoleWhat they receive
Standard dose vagal stimulationActive comparatorA total of 7 consecutive 2-minute trains at every 10 minutes for one hour (n=20)
Receives: Device: Gammacore device
High dose vagal stimulationActive comparatorA total of 7 consecutive 2-minute trains applied at every 10 minutes for one hour that is followed by an additional 7 consecutive 2-minute trains interspersed at every 10 minutes applied 3 hours after completion of the initial scheme (n=20)
Receives: Device: Gammacore device
Sham stimulationSham comparatorA total of 7 consecutive 2-minute trains at every 10 minutes for one hour (n=20)
Receives: Device: Gammacore sham device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular effects, clinical worsening or death (primary safety measure)

    any of the following:

    • severe bradycardia (HR ≤50/min) during treatment application
    • significant decrease in arterial blood pressure (≥20 mmHg decrease in mean arterial blood pressure) during treatment application
    • neurological worsening (progression of neurologic deficit as shown by ≥ 4 points increase in NIH Stroke Scale Score) within 24 hours
    • death within 24 hours

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2018
  2. Study start10 May 2019
  3. Primary completion31 Dec 2020
  4. Study completion1 Apr 2021

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03733431
Sponsor's protocol ID
TR-VENUS
Acronym
TR-VENUS
Status last verified
Oct 2021
First submitted
3 Nov 2018
Last updated
5 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Arsava EM, Topcuoglu MA, Ay I, Ozdemir AO, Gungor IL, Togay Isikay C, Nazliel B, Kozak HH, Ozturk S, Yilmaz IA, Dora B, Ay H; TR-VENUS investigators. Assessment of safety and feasibility of non-invasive vagus nerve stimulation for treatment of acute stroke. Brain Stimul. 2022 Nov-Dec;15(6):1467-1474. doi: 10.1016/j.brs.2022.10.012. Epub 2022 Nov 7.

    PubMed 36356829

Questions about this trial

What is this clinical trial studying?

A study testing Gammacore device in people with Stroke, Acute and Stroke, Ischemic, run by Turkish Stroke Research and Clinical Trials Network at 8 sites in Turkey (Türkiye).

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 3 inclusion and 26 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: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular effects, clinical worsening or death (primary safety measure) (time frame: 24 hours). 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 NCT03733431, 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 5 Oct 2021.

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