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

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ClinicalTrials.gov Identifier: NCT00826059
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
BrainsGate

January 19, 2009
January 21, 2009
October 12, 2018
January 2009
June 2018   (Final data collection date for primary outcome measure)
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.

  • Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ]
  • Safety measurements across all study population [ Time Frame: 90 days ]
Complete list of historical versions of study NCT00826059 on ClinicalTrials.gov Archive Site
Not Provided
  • Binary NIHSS [ Time Frame: 90 days ]
  • Dichotomous mRS [ Time Frame: 90 days ]
  • Subgroup analysis [ Time Frame: 90 days±7 days ]
    Primary parameters subgroup analysis by: NIHSS strata, lesion size, time from stroke onset strata, area of stroke, gender, age strata, Diabetes (Y/N), AFIB (Y/N) and side
  • 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)
  • Dichotomy 0-2 mRS at 3 months [ Time Frame: 90 days±7 days ]
    Functional independence at 3 months (modified Rankin Scale 0-2)
  • 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)
Not Provided
 
Implant for Augmentation of Cerebral Blood Flow Trial, Effectiveness and Safety in a 24 Hour Window
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.

A multi-center, multinational, randomized, double blind, sham control, adjunctive to Standard of Care, parallel arm study and will include ongoing 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 in a 1:1 (ISS Stimulation: Sham Control) ratio:

  • 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.

Following implantation, stimulation/sham stimulation will be delivered. Day 2-4 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 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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Device: Active Stimulation
    SPG stimulation and standard of care
  • Device: Sham Stimulation
    Sham SPG stimulation and standard of care
  • 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 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.

    Intervention: Device: Active Stimulation
  • 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.

    Intervention: Device: Sham Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
480
June 2018
June 2018   (Final data collection date for primary outcome measure)

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 ,IA-tPA 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.
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Georgia,   Germany,   Spain,   United States
 
 
NCT00826059
CLP1000500
Yes
Not Provided
Not Provided
BrainsGate
BrainsGate
Not Provided
Study Director: Eyal Shay BrainsGate
BrainsGate
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP