Acute Ischemic StrokeImpACT-24ANCT03767192
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window (ImpACT-24A)
A study testing Active Stimulation in people with Acute Ischemic Stroke, run by BrainsGate at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Active Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jan 2009to Mar 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥ 18 years and ≤ 85 of both genders.
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Baseline NIHSS ≥ 7 and ≤ 18
- Ability to initiate treatment within 8- 24 hours from stroke onset.
Who cannot join
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
- Previous stroke in the last 6 months or pre-existing disability
Show all 14Show fewer
- Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
- Known cerebral arteriovenous malformation, cerebral aneurysm.
- Clinical suspicion of septic embolus.
- Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg)
- 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).
- Life expectancy < 1 year from causes other than stroke.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Erlangen University Clinic
Erlangen
Essen University Clinic
Essen
Heidelberg University Clinic
Heidelberg
Leipzig University Clinic
Leipzig
Munster University Clinic
Münster
Spain2 sites
Hospital Vall d'Hebron
Barcelona
Hospital Universitari de Girona
Girona
United States1 site
Erlanger Stroke Center
Chattanooga, Tennessee, 37404
About this study
Official title: 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.
Read the detailed description
This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed. Later, it was decided to define the first part (before the halt) as a separate study - ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
Screening:
Treatment should be initiated between 8 and 24 hours from stroke onset. 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 in a 2:1 (ISS Stimulation: Sham Control) ratio:
Group 1: Implantation and ISS Stimulation during five consecutive days \& Standard of Care Group 2: Implantation and Sham Stimulation during five consecutive days \& Standard of Care The implantation will be performed by a trained physician. Stimulation/sham stimulation will be delivered Day 2-5 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed.
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 - 90±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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Active Stimulation, Sham Stimulation
- Keywords
- acute ischemic stroke, randomized clinical trial, effectiveness, safety
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active StimulationDevice
SPG stimulation and standard of care
Sham StimulationDevice
Sham SPG stimulation and standard of care
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Device: The Ischemic Stroke System SPG stimulation and standard of care Receives: Device: Active Stimulation |
| Sham Stimulation | Sham comparator | Device: Sham control Sham stimulation and standard of care Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Final global disability level on the modified Rankin scale (mRS) at 3 months better than expectation (sliding dichotomy analysis) ) assessed in the modified intention to treat (mITT) population defined as all randomized subjects receiving at least the minimal exposure of 1 treatment (ISS Stimulation or Sham Control) session out of the 5 planned sessions.
mRS Scale:
- 0 - No symptoms.
- 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
- 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- 3 - Moderate disability. Requires some help, but able to walk unassisted.
- 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- 6 - Dead.
Measured: 90 ±7 days
Number of participants with Serious Adverse Events
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
Measured: 90 ±7 days
Number of participants with neurological deterioration
Comparison between the active and sham stimulation groups of the rate of neurological deterioration, defined as an increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
Measured: 10 days
Number of participants with implantation complications
The rate of implantation complications as classified by the investigator
Measured: 90 ±7 days
Number of participants with stimulation-related adverse events
Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
Measured: 90 ±7 days
Mortality rate
Comparison of mortality rates between the active and sham stimulation groups
Measured: 90 ±7 days
Secondary outcomes (3)
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
mRS Scale:
- 0 - No symptoms.
- 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
- 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- 3 - Moderate disability. Requires some help, but able to walk unassisted.
- 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- 6 - Dead.
Measured: 90 ±7 days
Binary NIHSS at Day 90
Binary NIHSS (success for score ≤1 or for ≥ 9-point improvement versus baseline)
The NIHSS (National Institute of Health Stroke Score) is a 42-point scale that quantifies neurological deficits in 11 categories. Ratings for each item are scored with 3 to 5 grades, with 0 as normal.
Measured: 90 ±7 days
Stroke-related quality of life at 3 months: Stroke Impact Scale-16
Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16)
The scale is based on a questionnaire with 16 items. Each answer ranges from 1 (poor) to 5 (good). A final single-item Recovery domain assesses the individual's perception of his/her recovery from stroke, where:
0 = no recovery 100 = full recovery.
Domain scores range from 0-100 and are calculated using the following equation:
Domain score = [(Mean item score - 1) / (5-1) ] x 100
Measured: 90 ±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startJan 2009
- Primary completionJan 2011
- Study completionMar 2012
Why it stopped: Protocol Amendment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainsGate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eyal Shay, Study director, BrainsGate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767192
- Sponsor's protocol ID
- CLP1000500-24A
- Acronym
- ImpACT-24A
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Devlin T, Leung T, Molina CA; ImpACT-24A Investigators. Sphenopalatine Ganglion Stimulation to Augment Cerebral Blood Flow: A Randomized, Sham-Controlled Trial. Stroke. 2019 Aug;50(8):2108-2117. doi: 10.1161/STROKEAHA.118.024582. Epub 2019 May 23.
PubMed 31117920
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03767192
- Acronym / sponsor ID
- ImpACT-24A / CLP1000500-24A
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, randomized clinical trial, effectiveness, safety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol Amendment
- Enrolment
- 327 participants (actual)
- Lead sponsor
- BrainsGateIndustry (pharma, biotech, devices)
- Study start
- Jan 2009 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Dec 2018 (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 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.
Detailed description
This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24.
Background:
Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed. Later, it was decided to define the first part (before the halt) as a separate study - ImpACT-24A, and identify the continuation of the study as ImpACT-24B. ImpACT-24B continues to be registered as NCT00826059, and ImpACT-24A is registered in this new record.
Detailed Description:
A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study with ongoing DSMB review of accumulated safety data.
Screening:
Treatment should be initiated between 8 and 24 hours from stroke onset. 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 in a 2:1 (ISS Stimulation: Sham Control) ratio:
Group 1: Implantation and ISS Stimulation during five consecutive days \& Standard of Care Group 2: Implantation and Sham Stimulation during five consecutive days \& Standard of Care The implantation will be performed by a trained physician. Stimulation/sham stimulation will be delivered Day 2-5 ISS / Sham Stimulation will be repeated during the following four consecutive days by trained personnel within 18-26 hours from preceding stimulation.
Day 5 / Day of Discharge. Following the last ISS /Sham Stimulation, explantation will be performed.
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 - 90±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 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 |
|---|---|---|
| Active Stimulation | Experimental | Device: Active StimulationDevice: The Ischemic Stroke System SPG stimulation and standard of care |
| Sham Stimulation | Sham comparator | Device: Sham StimulationDevice: Sham control Sham stimulation and standard of care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥ 18 years and ≤ 85 of both genders.
- Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
- Baseline NIHSS ≥ 7 and ≤ 18
- Ability to initiate treatment within 8- 24 hours from stroke onset.
Key exclusion criteria (14 listed)
- Intracranial hemorrhage or hemorrhagic transformation
- Massive stroke
- Acute ischemic stroke in the posterior circulation
- Minor stroke
- Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
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 |
|---|---|---|
| Active StimulationSPG stimulation and standard of care | Device | Active Stimulation |
| Sham StimulationSham SPG stimulation and standard of care | Device | Sham Stimulation |
Primary outcome
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months
Time frame: 90 ±7 days
Final global disability level on the modified Rankin scale (mRS) at 3 months better than expectation (sliding dichotomy analysis) ) assessed in the modified intention to treat (mITT) population defined as all randomized subjects receiving at least the minimal exposure of 1 treatment (ISS Stimulation or Sham Control) session out of the 5 planned sessions. mRS Scale: * 0 - No symptoms. * 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. * 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. * 3 - Moderate disability. Requires some help, but able to walk unassisted. * 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. * 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. * 6 - Dead.
Number of participants with Serious Adverse Events
Time frame: 90 ±7 days
Comparison between the active and sham stimulation groups of all serious adverse events (SAEs)
Number of participants with neurological deterioration
Time frame: 10 days
Comparison between the active and sham stimulation groups of the rate of neurological deterioration, defined as an increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset
Number of participants with implantation complications
Time frame: 90 ±7 days
The rate of implantation complications as classified by the investigator
Number of participants with stimulation-related adverse events
Time frame: 90 ±7 days
Comparison between the active and sham stimulation groups of stimulation-related adverse events as classified by the investigator
Mortality rate
Time frame: 90 ±7 days
Comparison of mortality rates between the active and sham stimulation groups
3 secondary outcomes
Sliding Dichotomous 90-day mRS for patients with Aphasia at baseline
Time frame: 90 ±7 days
Binary NIHSS at Day 90
Time frame: 90 ±7 days
Stroke-related quality of life at 3 months: Stroke Impact Scale-16
Time frame: 90 ±7 days
Results and safety
The study was stopped early (reason given: Protocol Amendment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Derived from this study: PubMed 31117920Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Devlin T, Leung T, Molina CA; ImpACT-24A Investigators. Sphenopalatine Ganglion Stimulation to Augment Cerebral Blood Flow: A Randomized, Sham-Controlled Trial. Stroke. 2019 Aug;50(8):2108-2117. doi: 10.1161/STROKEAHA.118.024582. Epub 2019 May 23.
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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.
Eyal Shay study director
BrainsGate
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Stimulation in people with Acute Ischemic Stroke, run by BrainsGate at 8 sites in 3 countries.
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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Spain, United States. 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?
The study was stopped early (reason given: Protocol Amendment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sliding Dichotomy modified Rankin Scale (mRS) at 3 months (time frame: 90 ±7 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03767192, which also lists 1 linked publication.
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 28 Jan 2019.