Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24B)

February 17, 2020 updated by: BrainsGate

A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke

The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A multi-center, multinational, randomized, blinded, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing Data Safety and Monitoring Board (DSMB) review of accumulated safety data.

Screening:

Since the treatment should be initiated within 24 hours from stroke onset, the screening window is limited and all procedures should be performed within this window.Subjects with Acute Ischemic Stroke will be screened upon arrival to the hospital. Since the treatment should be initiated between 8 and 24 hours from stroke onset, the screening window is limited and all procedures should be performed as soon as possible. All screened patients will be identified by patient number and will sign the informed consent prior to any study procedure initiation.

Period 1: Day 1-5

Day 1- Eligible subjects will be randomized to:

  • Group 1: Implantation and ISS Stimulation during five consecutive days & Standard of Care
  • Group 2: Sham Implantation and Sham Stimulation during five consecutive days & Standard of Care Subjects will be transferred to the implantation procedure facility and the implantation/sham implantation will be performed by a trained physician.

After implantation, active/sham stimulation will be administered in daily 4-hour sessions, beginning immediately following the placement procedure and continuing for 5 consecutive days.

Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed and the patients will be evaluated for safety and effectiveness.

Subjects will continue with Standard of Care as needed and will be released from the hospital upon investigator's judgment.

Period 2: Day of Discharge - 89±7 days During this period both groups (ISS Stimulation and Sham Control) will be treated according to Standard of Care either at the hospital, rehabilitation center or at home.

Scheduled visits will be performed on day 30±7 and day 60 ±7, which will include safety and effectiveness assessments.

Final Visit Day 90±7 days: The final visit will be performed at the study site and will include safety and effectiveness evaluations.

Patients will be contacted by study personnel via telephone on Day 180±7 and on Day 360±7 in order to assess their quality of life status.

Study Type

Interventional

Enrollment (Actual)

1078

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences
      • Edmonton, Canada
        • Department of Medicine, Stroke Program, University of Alberta Hospital
  • Czechia
      • Poruba, Czechia
        • University Hospital of Ostrava, Ostrava Poruba
      • Prague, Czechia
        • General University Hospital
      • Vítkovice, Czechia
        • Vitkovicka nemocnice a.s. Ostrava Vitkovice
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Kuopio, Finland
        • Kuopio University Hospital
  • France
      • Brest, France
        • Hospital de la Cavale Blanche
      • Nantes, France
        • Hospital Nord Laennec
      • Nice, France
        • Hospital Saint Roch
      • Paris, France
        • Hopital Lariboisiere
      • Rennes, France
        • Hospital Pontchaillou
  • Georgia
      • Batumi, Georgia
        • Unimed Adjara Batumi Referral Hospital
      • Kutaisi, Georgia
        • Kutaisi Referral Hospital
      • Rustavi, Georgia
        • Rustavi Central Hospital
      • Tbilisi, Georgia
        • First University Clinic
      • Tbilisi, Georgia
        • Emergency Neurology Clinic Neurology Ltd.
      • Tbilisi, Georgia
        • High Technology Medical Center University Clinic LTD.
      • Zugdidi, Georgia
        • Zugdidi Referral Hospital
  • Germany
      • Altenburg, Germany
        • Altenburg Clinic of Neurology
      • Bad Neustadt An Der Saale, Germany
        • Bad Neustadt Neurological Clinic
      • Berlin, Germany
        • Center for Stroke Research at Charite University of Berlin
      • Erlangen, Germany
        • Erlangen University Clinic
      • Essen, Germany
        • Essen University Clinic
      • Heidelberg, Germany
        • Heidelberg University Clinic
      • Leipzig, Germany
        • Leipzig University Clinic
      • Munich, Germany
        • Technical University Munich
      • Villingen-Schwenningen, Germany
        • Schwarzwald-Baar Clinic
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Petah tikva, Israel
        • Rabin Medical Center
      • Tel Aviv, Israel
        • Sourasky Medical Center
      • Tel HaShomer, Israel
        • The Chaim Sheba Medical Center
  • Italy
      • Perugia, Italy
        • Hospital Sant'Andrea delle Fratte
      • Roma, Italy
        • Policlinico Umberto I
  • North Macedonia
      • Skopje, North Macedonia
        • University Clinic for Neurology
  • Poland
      • Białystok, Poland
        • Bialystok University Hospital
      • Końskie, Poland
        • Konske Hospital
      • Kraków, Poland
        • University Hospital in Krakow
      • Sandomierz, Poland
        • Sandomierz Hospital
      • Toruń, Poland
        • Toruń Hospital
      • Warsaw, Poland
        • Institute of Psychiatry and Neurology
  • Portugal
      • Amadora, Portugal
        • Hospital Fernando Fonseca
      • Porto, Portugal
        • Hospital de Santo António
      • Porto, Portugal
        • Unidade de AVC Centro Hospitalar São João
      • Santa Maria, Portugal
        • Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião
  • Serbia
      • Belgrade, Serbia
        • Special Hospital for Cerebrovascular Disease Sveti Sava
      • Novi Sad, Serbia
        • Clinical Centre of Vojvodina
      • Zemun, Serbia
        • Clinical Hospital Center Zemun
  • Slovakia
      • Nová Ves, Slovakia
        • Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská
      • Trnava, Slovakia
        • Neurologické Oddelenie FN Trnava, Fakultná Nemocnica
  • Spain
      • Albacete, Spain
        • Hospitalario Universitario de Albacete
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Ramon Y Cajal
      • Palma De Mallorca, Spain
        • Hospital Universitario Son Dureta
      • Santiago De Compostela, Spain
        • Complejo Hospitalarion Univiersitario de Santiago
      • Valladolid, Spain
        • Valladolid - Hospital Clinico
  • Ukraine
      • Lviv, Ukraine
        • Lviv National Medical University
  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Intercoastal Medical Group
    • Illinois
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Guilford Neurologic Associates
    • Ohio
      • Toledo, Ohio, United States, 43606
        • University of Toledo Medical Center- Campus 1
      • Toledo, Ohio, United States, 43606
        • University of Toledo Medical Center- Campus 2
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Stroke Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age: Between 40 years and 80 years for male and 85 for female subjects
  2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis
  4. Baseline NIHSS ≥ 7 and ≤ 18 within 2 hours prior to implantation.
  5. Ability to initiate treatment within 8- 24 hours from stroke onset
  6. Signed informed consent from patient him/herself or legally authorized representative if applicable

Exclusion Criteria:

  1. Intracranial hemorrhage or hemorrhagic transformation
  2. Massive stroke
  3. Acute ischemic stroke in the posterior circulation
  4. Minor stroke
  5. Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke
  6. Previous stroke in the last 6 months or pre-existing disability
  7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
  8. Clinical signs and symptoms or imaging evidence of bilateral stroke.
  9. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke.
  10. Known cerebral arteriovenous malformation, cerebral aneurysm.
  11. Clinical suspicion of septic embolus.
  12. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
  13. Serious systemic infection.
  14. Women known to be pregnant or having a positive or indeterminate pregnancy test.
  15. Patients with other implanted neural stimulator/ electronic devices (pacemakers).
  16. Life expectancy < 1 year from causes other than stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Active Stimulation

Implantation/ISS Stimulation during 5 consecutive days & Standard of Care (SoC).

Day 1: First stimulation initiated within 24 hours from stroke onset, following implantation completion. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke.

Day 2-4: ISS Stimulation treatment sessions repeated daily. Each treatment will be initiated within 18-26 hours from the preceding treatment.

Day 5: Following completion of the last ISS Stimulation treatment session, imaging performed for assessing Injectable Neuro Stimulator (INS) positioning and/or lesion. Implant removal procedure will then be performed. Subsequently, patients will be evaluated for safety and effectiveness.

Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator.
Device: Active Sphenopalatine Ganglion (SPG) Stimulation
SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
Other Names:
  • Standard of Care
SHAM_COMPARATOR: Sham Stimulation

Sham Implantation and Sham Stimulation during 5 consecutive days & Standard of Care (SoC).

Day 1: First Sham stimulation initiated within 24 hours from stroke onset, following Sham implantation procedure. All subjects will be treated according to SoC for treatment of Acute Ischemic Stroke.

Day 2-4: Sham Stimulation sessions repeated daily. Each Sham Stimulation will be initiated within 18-26 hours from the preceding treatment.

Day 5: Following completion of the last Sham Stimulation session, imaging performed for lesion assessment. Sham Implant removal will then be performed. Subsequently, patients will be evaluated for safety and effectiveness.

Subjects will continue with SoC as needed and discharged from the hospital based on the judgment of the study investigator.
Device: Sham Sphenopalatine Ganglion (SPG) Stimulation
Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.
Other Names:
  • Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Time Frame: 90 days±7 days

The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of:

  1. modified intention to treat (mITT)
  2. confirmed cortical involvement (CCI), defined as baseline NIHSS ≥ 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method.
90 days±7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subgroup analysis
Time Frame: 90 days±7 days
Primary parameters subgroup analysis by: NIHSS strata, lesion size, time from stroke onset strata, gender, age strata, Diabetes (Y/N), Atrial Fibrillation AFIB (Y/N) and side
90 days±7 days
Additional clinical efficacy outcome: SIS-16
Time Frame: 90 days±7 days
Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16)
90 days±7 days
Additional clinical efficacy outcome: Dichotomy 0-2 mRS at 3 months
Time Frame: 90 days±7 days
Functional independence at 3 months (modified Rankin Scale 0-2)
90 days±7 days
Additional clinical efficacy outcome: Dichotomy 0-3 mRS at 3 months
Time Frame: 90 days±7 days
Up to moderate disability but ambulatory at 3 months (modified Rankin Scale 0-3)
90 days±7 days
Safety outcome: Serious Adverse Event (SAE)
Time Frame: 90 days±7 days
All Serious Adverse Events (SAEs)
90 days±7 days
Safety outcome: Serious Adverse Event (SAE) - Implantation
Time Frame: 90 days±7 days
SAEs related to implant placement or removal
90 days±7 days
Safety outcome: Serious Adverse Event (SAE) - Stimulation
Time Frame: 90 days±7 days
SAEs related to stimulation
90 days±7 days
Safety outcome: Neurological Deterioration
Time Frame: 10 days
An increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
10 days
Safety outcome: Mortality
Time Frame: 90 days±7 days
Mortality
90 days±7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainsGate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2011

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

January 19, 2009

First Submitted That Met QC Criteria

January 20, 2009

First Posted (ESTIMATE)

January 21, 2009

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP1000500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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