Ischemic StrokeImpACT-PNCT04014621
Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial
A study testing SPG stimulation in people with Ischemic Stroke, run by BrainsGate at 4 sites in Georgia.
Trial summary
The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SPG stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesGeorgia
- Study dates
- 20 Oct 2019to 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs \& symptoms consistent with the diagnosis of large vessel occlusion in the anterior circulation
- Age 18-90 years
- Baseline NIHSS ≥ 10
- Ability to initiate treatment within 6 hours from stroke onset. Stroke onset is defined as the time the patient was last seen well.
- Large vessel total occlusion by CTA
- Penumbra ≥ 50ml (Difference between Tmax6 volume and the ischemic core volume (CBF<38% volume)
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- Mismatch (Tmax6 volume/ischemic core volume (CBF<38% volume) ≥1.5
- Core and HIR (Tmax10 / Tmax6) volumes: 1. HIR ≥ 0.5 or 2. 0.35 ≤ HIR < 0.5 and "core volume/time from onset to imaging" ≥ 7mililiter/hour
- Signed informed consent from patient him/herself or legally authorized representative.
Who cannot join
- Unable to undergo a contrast brain perfusion scan, including an allergy to contrast media
- Opportunity for reperfusion therapy (IV thrombolysis or endovascular treatment)
- Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm).
- Significant mass effect with midline shift.
- Infarct core volume >150 milliliter
- Old non-lacunar infarct in the anterior circulation on the ipsilateral hemisphere.
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- Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS > 0 for any reason
- Pre-existing Modified Rankin Score >1, even if not stroke-related.
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
- Seizures at stroke onset
- Baseline blood glucose of <50mg/dL (2.78 mmol) or >400mg/dL (22.20 mmol)
- Severe, sustained hypertension (Systolic BP >185 mmHg or Diastolic BP >110 mmHg)
- Current participation in another investigational drug or device study
- Presumed septic embolus; suspicion of bacterial endocarditis
- Clinical signs and symptoms or evidence for a relevant lesion by neuro-imaging of an acute ischemic stroke in the posterior circulation (Vertebral, Basilar and/or Posterior Cerebral Artery territories), including but not limited to brain-stem findings and/or cerebellar findings and/or isolated homonymous hemianopia or cortical blindness.
- Patients with bleeding propensity and/or one of the following: INR > 1.8, prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec., platelets count < 75×10^9/L.
- Serious systemic infection.
- Women known to be pregnant or having a positive or indeterminate pregnancy test.
- Patients with other implanted neural stimulator/ electronic devices (pacemakers).
- History of SPG ablation ipsilateral to the stroke side.
- Any condition in the oral cavity that prevents implantation of the INS.
- Known sensitivity to any medications to be used during study.
- Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Conditions may include: cardiovascular, vascular, pulmonary, hepatic, renal or neurological (other than acute ischemic stroke), or neoplastic diseases, as determined by medical history, physical examination, laboratory tests, or ECG.
- Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
Trial locations and contacts
4 sites in 1 country.
Georgia4 sites, 4 recruiting
- Recruiting
Academian Z.Tskhakaia West Georgia National Center of Interventional Medicine
Kutaisi
Tamar Janelidze, Dr.
- Not yet recruiting
Rustavi Central Hospital
Rustavi
Nino Kharaishvili, Dr.
- Recruiting
K. Eristavi National center of clinical and experimental surgery's hospital "New Life"
Tbilisi
Natia Zarkua, Dr.
- Not yet recruiting
LTD High Technology Medical Center University Clinic
Tbilisi
Giorgi Ingorokva, Prof.
About this study
Official title: A Multicenter, Randomized, Double Blind, Sham Controlled Trial to Assess the Efficacy of the Ischemic Stroke System (ISS) in Preventing Progressive Reduction of Salvageable Brain Tissue Volume in Subjects With Acute Ischemic Stroke
The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.
Read the detailed description
The goal of this study is to identify Acute Ischemic Stroke patients who have a potentially salvageable penumbra and to test if 6 hours of SPG (Sphenopalatine Ganglion) stimulation may "freeze" the volume of the penumbra and reduce the extent of tissue death.
Following a minimally-invasive implantation of the ISS injectable implant, patients will be randomized to either the Treated or Control arm in a 1:1 ratio. Randomization will be dynamic according to the patient's baseline covariates of core volume, total volume, Hypoperfusion Intensity Ratio (HIR), time to baseline imaging, age, NIHSS. Patients in the Treated arm will be treated with active SPG stimulation while patients in the Control arm will undergo sham treatment. After treatment/sham treatment, patients in both groups will undergo a follow up brain non-contrast CT, CT perfusion and CT angiography imaging, 6:45hrs±15min after baseline CTP initiation.
In the case the patient is cooperative, hand strength (pinch and grasp) evaluations should be assessed before and during the 1st treatment/ sham SPG stimulation session.
Following the assessment of the penumbra (after 6 hours) patients will be treated or sham treated for 5 additional consecutive sessions (4 hours each), the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation and will be followed for 90 days to assess their clinical outcome. In one session (preferably at day 2) Common Carotid Doppler examination is performed to evaluate blood flow dynamics before and during the treatment/sham session.
After the last treatment session, the implant is removed.
- Conditions
- Ischemic Stroke
- Being tested
- SPG stimulation
- Keywords
- acute ischemic stroke, randomized clinical trial, anterior circulation, penumbra
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPG stimulationDevice
The BrainsGate Ischemic Stroke System (ISS) consists of an implantable neurostimulator designed to deliver electrical stimulation to the sphenopalatine ganglion (SPG) and/or nerves within the greater palatine canal and pterygopalatine fossa.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Active comparator | Treated arm patients will be implanted and treated with one session of SPG stimulation for 6 hours and 5 additional consecutive sessions (4 hours each) of SPG stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation. Receives: Device: SPG stimulation |
| Control | Sham comparator | Control arm patients will be implanted and receive 6 hours of sham stimulation and 5 additional consecutive sessions (4 hours each) of sham stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation. Receives: Device: SPG stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of core expansion
The primary outcome measure is the volume of core expansion (in milliliters) in 6:45h±15 min. Core expansion is the difference of two volumes: Core volume (CBF<38%) in follow up CTP (at 6:45h±15 min) and Core volume (CBF<38%) in baseline CTP.
The difference in the mean core expansion between the Treated and Control groups will be assessed as a continuous variable with adjustment for baseline covariates (Core volume, Total volume, HIR, Time to baseline imaging).
The two-sided significance level is 0.05.
Handling of missing data in the primary analysis:
Patients who die before the 6:45h±15 min follow-up imaging will be assigned a final core volume that equal the baseline total volume.
Patients with non-interpretable follow-up imaging will be excluded from the analysis.
Measured: Day 1
Secondary outcomes (5)
Difference in infarct volume between baseline CTP core volume and follow up NCCT infarct volume.
Difference in infarct volume (in milliliters) between baseline CTP core volume (CBF<38%) and follow up 6:45h±15 min NCCT infarct volume, adjusted using stratification parameters (Core volume, Total volume, HIR, Time to baseline imaging).
Measured: Day 1
Difference in infarct volume between baseline CTP core volume and Day-5 NCCT infarct volume
Difference in infarct volume (in milliliters) between baseline CTP core volume (CBF<38%) and Day-5 NCCT infarct volume, adjusted using stratification parameters (Core volume, Total volume, HIR, Time to baseline imaging).
Measured: Day 5
3 months mRS
mRS at 90-day:
- Utility weighted mRS
- mRS Dichotomy 0-2
- mRS Dichotomy 0-3
Measured: Day 90±7
Increased blood flow in Common Carotid Doppler
Increased blood flow in Common Carotid Doppler (if available).
Measured: Day 2-6
Improvement in hand motor performance
Improvement in hand motor performance (if available) using a hand dynamometer (Baseline Hydraulic Hand Dynamometers, Fabrication Enterprises Inc, White Plains NY, USA).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start20 Oct 2019
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BrainsGate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Slolberg, Dr., Study director, BrainsGate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014621
- Sponsor's protocol ID
- CLP0050615
- Acronym
- ImpACT-P
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Sham Controlled Trial to Assess the Efficacy of the Ischemic Stroke System (ISS) in Preventing Progressive Reduction of Salvageable Brain Tissue Volume in Subjects With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04014621
- Acronym / sponsor ID
- ImpACT-P / CLP0050615
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, randomized clinical trial, anterior circulation, penumbra
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- BrainsGateIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 10 Jul 2019 (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 primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.
Detailed description
The goal of this study is to identify Acute Ischemic Stroke patients who have a potentially salvageable penumbra and to test if 6 hours of SPG (Sphenopalatine Ganglion) stimulation may "freeze" the volume of the penumbra and reduce the extent of tissue death.
Following a minimally-invasive implantation of the ISS injectable implant, patients will be randomized to either the Treated or Control arm in a 1:1 ratio. Randomization will be dynamic according to the patient's baseline covariates of core volume, total volume, Hypoperfusion Intensity Ratio (HIR), time to baseline imaging, age, NIHSS. Patients in the Treated arm will be treated with active SPG stimulation while patients in the Control arm will undergo sham treatment. After treatment/sham treatment, patients in both groups will undergo a follow up brain non-contrast CT, CT perfusion and CT angiography imaging, 6:45hrs±15min after baseline CTP initiation.
In the case the patient is cooperative, hand strength (pinch and grasp) evaluations should be assessed before and during the 1st treatment/ sham SPG stimulation session.
Following the assessment of the penumbra (after 6 hours) patients will be treated or sham treated for 5 additional consecutive sessions (4 hours each), the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation and will be followed for 90 days to assess their clinical outcome. In one session (preferably at day 2) Common Carotid Doppler examination is performed to evaluate blood flow dynamics before and during the treatment/sham session.
After the last treatment session, the implant is removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | Active comparator | Device: SPG stimulationTreated arm patients will be implanted and treated with one session of SPG stimulation for 6 hours and 5 additional consecutive sessions (4 hours each) of SPG stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation. |
| Control | Sham comparator | Device: SPG stimulationControl arm patients will be implanted and receive 6 hours of sham stimulation and 5 additional consecutive sessions (4 hours each) of sham stimulation, the first starting within 18-24 hours from stroke onset and the others 18-26 hours from previous treatment initiation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signs \& symptoms consistent with the diagnosis of large vessel occlusion in the anterior circulation
- Age 18-90 years
- Baseline NIHSS ≥ 10
- Ability to initiate treatment within 6 hours from stroke onset. Stroke onset is defined as the time the patient was last seen well.
- Large vessel total occlusion by CTA
Key exclusion criteria (24 listed)
- Unable to undergo a contrast brain perfusion scan, including an allergy to contrast media
- Opportunity for reperfusion therapy (IV thrombolysis or endovascular treatment)
- Neuro-imaging evidence of any intracranial hemorrhage or hemorrhagic transformation of brain infarct or other significant abnormality (e.g. tumor, abscess, suspect for subarachnoid hemorrhage, arteriovenous malformation, cerebral aneurysm).
- Significant mass effect with midline shift.
- Infarct core volume >150 milliliter
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 |
|---|---|---|
| SPG stimulationThe BrainsGate Ischemic Stroke System (ISS) consists of an implantable neurostimulator designed to deliver electrical stimulation to the sphenopalatine ganglion (SPG) and/or nerves within the greater palatine canal and pterygopalatine fossa. | Device | Control, Treated |
Primary outcome
Volume of core expansion
Time frame: Day 1
The primary outcome measure is the volume of core expansion (in milliliters) in 6:45h±15 min. Core expansion is the difference of two volumes: Core volume (CBF<38%) in follow up CTP (at 6:45h±15 min) and Core volume (CBF<38%) in baseline CTP. The difference in the mean core expansion between the Treated and Control groups will be assessed as a continuous variable with adjustment for baseline covariates (Core volume, Total volume, HIR, Time to baseline imaging). The two-sided significance level is 0.05. Handling of missing data in the primary analysis: Patients who die before the 6:45h±15 min follow-up imaging will be assigned a final core volume that equal the baseline total volume. Patients with non-interpretable follow-up imaging will be excluded from the analysis.
5 secondary outcomes
Difference in infarct volume between baseline CTP core volume and follow up NCCT infarct volume.
Time frame: Day 1
Difference in infarct volume between baseline CTP core volume and Day-5 NCCT infarct volume
Time frame: Day 5
3 months mRS
Time frame: Day 90±7
Increased blood flow in Common Carotid Doppler
Time frame: Day 2-6
Improvement in hand motor performance
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yoram Slolberg, Dr. study director
BrainsGate
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPG stimulation in people with Ischemic Stroke, run by BrainsGate at 4 sites in Georgia.
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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Segev (+972 4 637 7774 ext. 115, michaels@brainsgate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of core expansion (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2019.