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Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke (ImpACT-1)

Primary Purpose

Ischemic Stricture of Intestine

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

ISS Active Stimulation

About this trial

This is an interventional treatment trial for Ischemic Stricture of Intestine focused on measuring Ischemic Stroke, Treatment, ISS, ImpACT, clinical trial

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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)

Sites / Locations

Postgraduate Institute of Medical Education and Research
Nizam's Institute of Medical Research Punjagutta, Hyderabad.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

Treatment successful completion

The need to stop the treatment sessions completely or alternately.

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.

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03733236

First Posted

November 1, 2018

Last Updated

July 24, 2019

Sponsor

BrainsGate

1. Study Identification

Unique Protocol Identification Number

NCT03733236

Brief Title

Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke

Acronym

ImpACT-1

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 6, 2006 (Actual)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BrainsGate

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stricture of Intestine

Keywords

Ischemic Stroke, Treatment, ISS, ImpACT, clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

ISS Active Stimulation

Intervention Description

ISS SPG stimulation and standard of care

Primary Outcome Measure Information:

Title

Treatment successful completion

Description

The need to stop the treatment sessions completely or alternately.

Time Frame

5 Days

Title

Adverse Events profile at 90 Day compared to VISTA trials data

Description

Adverse Events profile at 90 days post implantation will be compared to the data retrieved form the VISTA trials.

Time Frame

90 Days

Secondary Outcome Measure Information:

Title

The distribution of modified Rankin scale scores at 90 days

Description

Shift in the distribution of modified Rankin Scale (mRS) scores at 90 days Favorable outcome is mRS score between 0 and 2

Time Frame

90 Days

Title

NIHSS scores at 90 days

Description

Time Frame

90 Days

Title

Proportion of patients achieving a Barthel index at 90 days

Description

The proportion of patients achieving a Barthel index of 95-100 (versus 0-90) at 90 days

Time Frame

90 Days

Other Pre-specified Outcome Measures:

Title

Patient and treatment compliance to the stimulation

Description

The ability to maintain treatment in each session for the treatment length, and the compliance for the whole treatment period; i.e. each treatment session should be performed for at least 85% of the prescribed regimen

Time Frame

5 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Subash Kaul, Dr.

Organizational Affiliation

Nizam's Institute of Medical Research Punjagutta, Hyderabad.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Postgraduate Institute of Medical Education and Research

City

Chandigarh

Country

India

Facility Name

Nizam's Institute of Medical Research Punjagutta, Hyderabad.

City

Hyderabad

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

31269025

Citation

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.

Results Reference

derived

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Safety and Effectiveness Evaluation of the ISS System in Treatment of Acute Ischemic Stroke

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