Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial

NCT04014621 | Unknown DMC

• 1 other identifier: CLP0050615
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke; randomized clinical trial; anterior circulation; penumbra

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (5)

• Difference in infarct volume between baseline CTP core volume and follow up NCCT infarct volume.

  Day 1

• Difference in infarct volume between baseline CTP core volume and Day-5 NCCT infarct volume

  Day 5

• 3 months mRS

  Day 90±7

• Increased blood flow in Common Carotid Doppler

  Day 2-6

• Improvement in hand motor performance

  Day 1

Other Outcomes (4)

• Safety Data Between the Treatment and Control Arms - Serious Adverse Events

  Day 90±7

• Safety Data Between the Treatment and Control Arms - Mortality

  Day 90±7

• Safety Data Between the Treatment and Control Arms - Symptomatic Intracranial hemorrhage (sICH) SAEs

  Day 5

Study Arms (2)

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.

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.

Device: SPG stimulation

Interventions

SPG stimulation DEVICE

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; Treated

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• BrainsGate: lead

Study Sites (4)

Academian Z.Tskhakaia West Georgia National Center of Interventional Medicine

Kutaisi, Georgia

RECRUITING

Rustavi Central Hospital

Rustavi, Georgia

NOT YET RECRUITING

K. Eristavi National center of clinical and experimental surgery's hospital "New Life"

Tbilisi, Georgia

RECRUITING

LTD High Technology Medical Center University Clinic

Tbilisi, Georgia

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yoram Slolberg, Dr.

  BrainsGate

  STUDY DIRECTOR

Central Study Contacts

Michael Segev

CONTACT

+972 4 637 7774; michaels@brainsgate.com

Noam Levy

CONTACT

+972 4 637 7774; noaml@brainsgate.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: July 10, 2019
• Study Start: October 20, 2019
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GE (4)