Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial
NCT ID: NCT04014621
Last Updated: 2019-10-30
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-10-20
2021-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
NCT00826059
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)
NCT03767192
Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window
NCT04256096
EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke
NCT02216643
Endovascular Acute Stroke Intervention - Tandem OCclusion Trial
NCT04261478
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treated
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.
SPG stimulation
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.
Control
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.
SPG stimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPG stimulation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-90 years
3. Baseline NIHSS ≥ 10
4. Ability to initiate treatment within 6 hours from stroke onset. Stroke onset is defined as the time the patient was last seen well.
5. Large vessel total occlusion by CTA
6. Penumbra ≥ 50ml (Difference between Tmax6 volume and the ischemic core volume (CBF\<38% volume)
7. Mismatch (Tmax6 volume/ischemic core volume (CBF\<38% volume) ≥1.5
8. 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
9. Signed informed consent from patient him/herself or legally authorized representative.
Exclusion Criteria
2. Opportunity for reperfusion therapy (IV thrombolysis or endovascular treatment)
3. 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).
4. Significant mass effect with midline shift.
5. Infarct core volume \>150 milliliter
6. Old non-lacunar infarct in the anterior circulation on the ipsilateral hemisphere.
7. Previous stroke in the last 6 months or previous stroke with existing sequelae or with mRS \> 0 for any reason
8. Pre-existing Modified Rankin Score \>1, even if not stroke-related.
9. 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).
10. Seizures at stroke onset
11. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol)
12. Severe, sustained hypertension (Systolic BP \>185 mmHg or Diastolic BP \>110 mmHg)
13. Current participation in another investigational drug or device study
14. Presumed septic embolus; suspicion of bacterial endocarditis
15. 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.
16. 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.
17. Serious systemic infection.
18. Women known to be pregnant or having a positive or indeterminate pregnancy test.
19. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
20. History of SPG ablation ipsilateral to the stroke side.
21. Any condition in the oral cavity that prevents implantation of the INS.
22. Known sensitivity to any medications to be used during study.
23. 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.
24. Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study.
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BrainsGate
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yoram Slolberg, Dr.
Role: STUDY_DIRECTOR
BrainsGate
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Academian Z.Tskhakaia West Georgia National Center of Interventional Medicine
Kutaisi, , Georgia
Rustavi Central Hospital
Rustavi, , Georgia
K. Eristavi National center of clinical and experimental surgery's hospital "New Life"
Tbilisi, , Georgia
LTD High Technology Medical Center University Clinic
Tbilisi, , Georgia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tamar Janelidze, Dr.
Role: primary
Nino Kharaishvili, Dr.
Role: primary
Natia Zarkua, Dr.
Role: primary
Giorgi Ingorokva, Prof.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLP0050615
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.