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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by BrainsGate
Sponsor:
Information provided by (Responsible Party):
BrainsGate
ClinicalTrials.gov Identifier:
NCT00826059
First received: January 19, 2009
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Device: The Ischemic Stroke System
Device: Sham control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BrainsGate:

Primary Outcome Measures:
  • Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

    The primary effectiveness endpoint will be the modified Rankin Scale (mRS) evaluated by the site on Day 90±7.

    The statistical analysis of the primary effectiveness endpoint will be: Sliding Dichotomous mRS.



Secondary Outcome Measures:
  • Sliding Dichotomous mRS for subjects with aphasia at baseline [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Binary NIHSS (success for score ≤ 1 or for ≥ 9-point improvement versus baseline) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: January 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Stimulation Device: The Ischemic Stroke System
SPG stimulation and standard of care
Sham Comparator: Sham Stimulation Device: Sham control
Sham stimulation and standard of care

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826059

Contacts
Contact: Noam Zilberman noamz@brainsgate.com

Locations
United States, Florida
Intercoastal Medical Group Recruiting
Sarasota, Florida, United States, 34232
United States, Illinois
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
United States, Massachusetts
UMASS Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
United States, Ohio
ProMedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
Erlanger Stroke Center Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Texas
The Methodist Hospital System Recruiting
Houston, Texas, United States, 77030
Germany
Erlangen University Clinic Recruiting
Erlangen, Germany
Essen University Clinic Recruiting
Essen, Germany
Heidelberg University Clinic Recruiting
Heidelberg, Germany
Leipzig University Clinic Recruiting
Leipzig, Germany
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain
Sponsors and Collaborators
BrainsGate
  More Information

No publications provided

Responsible Party: BrainsGate
ClinicalTrials.gov Identifier: NCT00826059     History of Changes
Other Study ID Numbers: CLP1000500
Study First Received: January 19, 2009
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by BrainsGate:
acute ischemic stroke
randomized clinical trial
effectiveness
safety

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 24, 2014