Ischemic Stricture of IntestineImpACT-1NCT03733236
Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke
A study testing ISS Active Stimulation in people with Ischemic Stricture of Intestine, run by BrainsGate at 2 sites in India.
Trial summary
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stricture of Intestine
- What is being tested?
- ISS Active Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesIndia
- Study dates
- 6 Jul 2006to Jan 2009
- 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
- Patients with symptoms and signs of an acute ischemic hemispheric stroke within the anterior circulation.
- NIHSS ≥ 7 and ≤ 20
- Treatment can be initiated within the first 24 hours following stroke onset or since last seen normal.
- Signed informed consent has been obtained from the patient him/herself or his/her legally authorized representative
Who cannot join
- Time interval since onset of symptoms undetermined
- Treatment with ISS500 System can't start within the first 24 hours post stroke onset
- Any other imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1-PH2) (H1 and H2 are allowed); or symptoms suspicious for sub-arachnoid hemorrhage, etc
- Clinical syndrome of an acute stroke due to lacunar infarct (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size
- Not a stroke in the anterior circulation
- Minor stroke with non-disabling deficit or rapidly improving neurological symptoms with a high probably to Transient Ischemic Attack (TIA)
Show all 32Show fewer
- Eligible to or treated with IV or IA t-PA or mechanical thrombolysis
- Baseline NIHSS >20 or < 7
- Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2)
- History of stroke in previous 6 months
- Pre-existing disability; Modified Rankin Score > 2 upon screening
- Patients under oral anticoagulants or having received heparin within 48 hours, and / or with elevated activated partial thromboplastin time (aPTT) (or INR)
- High clinical suspicion of septic embolus
- Severe cardiac disease: evidence of congestive heart failure or has history of endstage cardiovascular disease (e.g. CHF NYHA Class III or IV or unstable angina)
- Uncontrolled hypertension upon enrollment (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
- Orthodontics or non-Hygienic condition/ problems that prevent procedures within the mouth
- MRI2 contraindications, such as but not limited to:
- Central nervous system aneurysm clips
- Implanted cardiac pacemaker or defibrillator;
- Cochlear implant
- Ocular foreign body (e.g. metal shavings)
- Insulin pump
- Metal shrapnel or bullet
- Any implanted device that is incompatible with MRI.
- Patients with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)
- Life expectancy < 1 year from other causes
- Currently participating in any other clinical trial
- Patients unable or unwilling to follow protocol requirements
- Massive stroke, defined as acute parenchymal hypodense lesion or effacement of cerebral sulci in over a 2/3 of the MCA territory per CT (or equivalent per T2/Flair/DWI MRI)
Trial locations and contacts
2 sites in 1 country.
India2 sites
Postgraduate Institute of Medical Education and Research
Chandigarh
Nizam's Institute of Medical Research Punjagutta, Hyderabad.
Hyderabad
About this study
Official title: Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
The primary objective of this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.
Read the detailed description
The study is an open label study in which a comparative group of patients will be prospectively selected from a resource of clinical trial data, the Virtual International Stroke Trials Archive (VISTA), on the basis of similar eligibility criteria and match for principal prognostic variables available at trial entry. Data from patients will be transferred to VISTA in a real time or at most, weekly basis and comparative group patients will be prospectively matched throughout the recruitment period. The VISTA investigators will be blinded to treatment group when receiving data from BrainsGate. The VISTA investigators will match each recruited BrainsGate patient with 3 patients from the VISTA archive. The matching criteria will include age ± 4 years; baseline NIH score matched exactly, and side of infarct.
In addition, to the end of treatment visit, in which implanted patients will undergo a device removal procedure, two follow-up visits will be performed. The visits should be performed at 30±5, and at 90±5 post enrollment. Aggregate trial duration will be ~100 days per patient, and the overall study duration will be up to 18 months.
- Conditions
- Ischemic Stricture of Intestine
- Being tested
- ISS Active Stimulation
- Keywords
- Ischemic Stroke, Treatment, ISS, ImpACT, clinical trial
- Medical subject headings
- Ischemic Stroke, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISS Active StimulationDevice
ISS SPG stimulation and standard of care
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | The Implant will be implanted using a minimal invasive approach. Following implantation, a CT localization imaging should be performed as soon as possible following the implant procedure. ISS (Ischemic Stroke System) stimulation of the SPG (Sphenopalatine Ganglionduring) for 5 consecutive days. Receives: Device: ISS Active Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment successful completion
The need to stop the treatment sessions completely or alternately.
Measured: 5 Days
Adverse Events profile at 90 Day compared to VISTA trials data
Adverse Events profile at 90 days post implantation will be compared to the data retrieved form the VISTA trials.
Measured: 90 Days
Secondary outcomes (3)
The distribution of modified Rankin scale scores at 90 days
Shift in the distribution of modified Rankin Scale (mRS) scores at 90 days Favorable outcome is mRS score between 0 and 2
Measured: 90 Days
NIHSS scores at 90 days
The distribution of total NIHSS scores at 90 days - binary NIHSS (defined as the proportion of favorable outcomes assessed using the NIHSS scale, where as favorable outcome was a complete recovery (NIHSS 0 or 1) or an improvement by 9 or more points in the NIHSS score
Measured: 90 Days
Proportion of patients achieving a Barthel index at 90 days
The proportion of patients achieving a Barthel index of 95-100 (versus 0-90) at 90 days
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start6 Jul 2006
- Primary completionJan 2009
- Study completionJan 2009
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 Ischemic Stricture of IntestineStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- BrainsGate
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Subash Kaul, Dr., Principal investigator, Nizam's Institute of Medical Research Punjagutta, Hyderabad.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733236
- Sponsor's protocol ID
- CLP1000450
- Acronym
- ImpACT-1
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khurana D, Kaul S, Schneider D, Csanyi A, Adam I, Ichaporia NR, Griewing B, Csiba L, Valikovics A, Puri V, Diener HC, Schwab S, Hetzel A, Bornstein N; ImpACT-1 Study Group. Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke. PLoS One. 2019 Jul 3;14(7):e0217472. doi: 10.1371/journal.pone.0217472. eCollection 2019.
PubMed 31269025
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant for Augmentation of Cerebral Blood Flow Trial-1. A Pilot Study Evaluating the Safety and Effectiveness of the Ischemic Stroke System for Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03733236
- Acronym / sponsor ID
- ImpACT-1 / CLP1000450
- Conditions
- Ischemic Stricture of Intestine
- Keywords
- Ischemic Stroke, Treatment, ISS, ImpACT, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- BrainsGateIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2006 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 Nov 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 this pilot study is the assessment of the safety of the ISS500 System in patients who have experienced an acute ischemic stroke within the anterior circulation.
The secondary objectives of this study are to examine the effectiveness of the ISS500 System implantation in the treatment of acute ischemic stroke.
Detailed description
The study is an open label study in which a comparative group of patients will be prospectively selected from a resource of clinical trial data, the Virtual International Stroke Trials Archive (VISTA), on the basis of similar eligibility criteria and match for principal prognostic variables available at trial entry. Data from patients will be transferred to VISTA in a real time or at most, weekly basis and comparative group patients will be prospectively matched throughout the recruitment period. The VISTA investigators will be blinded to treatment group when receiving data from BrainsGate. The VISTA investigators will match each recruited BrainsGate patient with 3 patients from the VISTA archive. The matching criteria will include age ± 4 years; baseline NIH score matched exactly, and side of infarct.
In addition, to the end of treatment visit, in which implanted patients will undergo a device removal procedure, two follow-up visits will be performed. The visits should be performed at 30±5, and at 90±5 post enrollment. Aggregate trial duration will be ~100 days per patient, and the overall study duration will be up to 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: ISS Active StimulationThe Implant will be implanted using a minimal invasive approach. Following implantation, a CT localization imaging should be performed as soon as possible following the implant procedure. ISS (Ischemic Stroke System) stimulation of the SPG (Sphenopalatine Ganglionduring) for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: ≥ 18 years and ≤ 85 of both genders
- Patients with symptoms and signs of an acute ischemic hemispheric stroke within the anterior circulation.
- NIHSS ≥ 7 and ≤ 20
- Treatment can be initiated within the first 24 hours following stroke onset or since last seen normal.
- Signed informed consent has been obtained from the patient him/herself or his/her legally authorized representative
Key exclusion criteria (32 listed)
- Time interval since onset of symptoms undetermined
- Treatment with ISS500 System can't start within the first 24 hours post stroke onset
- Any other imaging diagnosis including tumor, abscess, primary intracranial hemorrhage (ICH) or secondary hemorrhage (PH1-PH2) (H1 and H2 are allowed); or symptoms suspicious for sub-arachnoid hemorrhage, etc
- Clinical syndrome of an acute stroke due to lacunar infarct (pure motor hemiparesis, ataxic hemiparesis, sensorimotor stroke), unless brain imaging demonstrates a relevant lesion > 1.5 cm in size
- Not a stroke in the anterior circulation
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 |
|---|---|---|
| ISS Active StimulationISS SPG stimulation and standard of care | Device | Active Stimulation |
Primary outcome
Treatment successful completion
Time frame: 5 Days
The need to stop the treatment sessions completely or alternately.
Adverse Events profile at 90 Day compared to VISTA trials data
Time frame: 90 Days
Adverse Events profile at 90 days post implantation will be compared to the data retrieved form the VISTA trials.
3 secondary outcomes
The distribution of modified Rankin scale scores at 90 days
Time frame: 90 Days
NIHSS scores at 90 days
Time frame: 90 Days
Proportion of patients achieving a Barthel index at 90 days
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Derived from this study: PubMed 31269025Khurana D, Kaul S, Schneider D, Csanyi A, Adam I, Ichaporia NR, Griewing B, Csiba L, Valikovics A, Puri V, Diener HC, Schwab S, Hetzel A, Bornstein N; ImpACT-1 Study Group. Implant for Augmentation of Cerebral Blood Flow Trial-1 (ImpACT-1). A single-arm feasibility study evaluating the safety and potential benefit of the Ischemic Stroke System for treatment of acute ischemic stroke. PLoS One. 2019 Jul 3;14(7):e0217472. doi: 10.1371/journal.pone.0217472. eCollection 2019.
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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.
Subash Kaul, Dr. principal investigator
Nizam's Institute of Medical Research Punjagutta, Hyderabad.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISS Active Stimulation in people with Ischemic Stricture of Intestine, run by BrainsGate at 2 sites in India.
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 5 inclusion and 32 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: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment successful completion (time frame: 5 Days). The study lists 2 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 NCT03733236, 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 25 Jul 2019.