Evaluation of the SONAS® ultrasound device for the assessment of blood flow in the two sides of the brain in subjects with acute stroke

Phase 1

• Conditions: Acute large vessel occlusion (LVO) stroke (NIHSS score: = 10); MedDRA version: 20.0Level: LLTClassification code 10042244Term: StrokeSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-001279-19-DE
• Lead Sponsor: BURL Concepts, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-19
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Written informed consent obtained
2. Male or female aged at least 18
3. Clinical diagnosis of acute stroke (NIHSS score: =10)
4. Time of stroke symptoms onset: =24 hours
5. Confirmed occlusion of either the proximal middle cerebral artery (occlusion of the proximal, middle or distal M1-segment) or the distal internal carotid artery (including carotid-T occlusion) by cMRI or cCT (including perfusion weighted imaging sequences)
6. Women of childbearing potential must have a negative urine or serum beta human chorionic gonadotropin result, obtained within 24 hours before administration of SonoVue®
7. Women of non-childbearing potential can be included in the clinical investigation, if confirmed by fulfilling at least 1 of the following criteria:
• Postmenopausal (age-related amenorrhea for =12 consecutive months)
• Documentation (based on medical records, medical examination, or medical history interview) of irreversible surgical sterilization by bilateral oophorectomy, bilateral salpingectomy, or hysterectomy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subjects with known contraindications to the use of SonoVue®:
• Subjects known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and subjects with acute respiratory distress syndrome
• SonoVue® must not be used in combination with dobutamine in subjects with conditions suggesting cardiovascular instability where dobutamine is contraindicated
• Known hypersensitivity to any of the following substances:
o Sulphur hexafluoride
o Macrogol 4000
o Distearoylphosphatidylcholine
o Dipalmitoylphosphatidylglycerol sodium
o Palmitic acid
2. Pregnant women
3. Subjects with severe cardiac or pulmonary disease as defined by the treating physician
4. Subjects with acute endocarditis and/or artificial heart valve
5. Subjects with acute systemic inflammation and/or sepsis
6. Subjects with hyperactive coagulation states and/or a recent thromboembolism
7. Subjects with end stage renal or hepatic disease
8. Subjects with known metal skull implants in the anatomical area of the temporal/parietal bones, or with anatomical formation of the head or ear that may interfere with proper headset placement, or with significant observable asymmetry in head formation
9. Subjects with known implanted deep brain stimulation devices
10. Subjects with known or suspected fracture(s) of the temporal/parietal skull bones, or with open skin injuries in the anatomical area of the temporal/parietal lobes
11. Subjects with known significant blood loss prior to or during the test procedure, SONAS® should not be used unless the blood pressure of the subject is verified to be stabilized
12. Subjects with axial (coronal) skull diameters of <12 cm or >18 cm
13. Subjects participating in another clinical investigation with an investigational drug or device within 3 months of enrollment or planned participation at any time during this clinical investigation
14. Previous participation in this clinical investigation
15. Employees of the clinical investigation site or the sponsor directly involved with the conduct of the clinical investigation, or immediate family members of any such individuals
16. Subjects committed to an institution by an order issued either by the courts or by an authority

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety and feasibility of detecting acoustic signals related to blood supply in subjects with acute large vessel occlusion (LVO) stroke by using the SONAS® device.<br><br>;Secondary Objective: Not applicable;Primary end point(s): • Measurement of the kinetic parameter time to peak (TTP) in the right and left brain hemisphere during the SONAS® test<br>• Assessment of intra-individual differences in the parameter TTP in the right and left brain hemisphere during the SONAS® test<br>• Comparison between SONAS® versus cMRI or cCT generated intra-individual differences in the parameter TTP in the right and left brain hemisphere<br>• Measurement of other kinetic parameters (e.g. TI, TA, hPmax_incline, Pmax, hPmax_recede, 80%Pmax_recede, and MTT) in the right and left brain hemisphere during the SONAS® test and evaluations as defined for TTP<br><br><br>;Timepoint(s) of evaluation of this end point: Day 0; day 1 (24 hours after first SONAS test)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency, severity, relationship (device, contrast agent, or procedure) and outcome of adverse events (AEs);Timepoint(s) of evaluation of this end point: Day 0; day 1 (24 hours after first SONAS test); day 4 (72 hours after second SONAS test)