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 September 2014 by BrainsGate
Sponsor:
Information provided by (Responsible Party):
BrainsGate
ClinicalTrials.gov Identifier:
NCT00826059
First received: January 19, 2009
Last updated: September 11, 2014
Last verified: September 2014

January 19, 2009
September 11, 2014
January 2009
January 2016   (final data collection date for primary outcome measure)
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.

  • Distribution of patients across the ordinal modified Rankin scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Safety measurements across all study population [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00826059 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Binary NIHSS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Dichotomous mRS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Not Provided
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ischemic Stroke
  • Device: The Ischemic Stroke System
    SPG stimulation and standard of care
  • Device: Sham control
    Sham stimulation and standard of care
  • Experimental: Active Stimulation
    Intervention: Device: The Ischemic Stroke System
  • Sham Comparator: Sham Stimulation
    Intervention: Device: Sham control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
January 2016
January 2016   (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.
Both
40 Years to 85 Years
No
Contact: Noam Zilberman noamz@brainsgate.com
United States,   Germany,   Spain
 
NCT00826059
CLP1000500
Yes
BrainsGate
BrainsGate
Not Provided
Not Provided
BrainsGate
September 2014

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