Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

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

Lead Sponsor:

BrainsGate

Conditions:

Acute Ischemic Stroke

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief Summary

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 h...

Detailed Description

This study was first registered as NCT00826059 on January 19, 2009 under the name ImpACT-24. Background: Recruitment to ImpACT-24 was halted, the protocol was amended and then the study was resumed....

Eligibility Criteria

Inclusion

  • Age: ≥ 18 years and ≤ 85 of both genders.
  • Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories
  • Baseline NIHSS ≥ 7 and ≤ 18
  • Ability to initiate treatment within 8- 24 hours from stroke onset.

Exclusion

  • Intracranial hemorrhage or hemorrhagic transformation
  • Massive stroke
  • Acute ischemic stroke in the posterior circulation
  • Minor stroke
  • Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke
  • Previous stroke in the last 6 months or pre-existing disability
  • Patients with bleeding propensity or any condition in the oral cavity that prevents implantation
  • Known cerebral arteriovenous malformation, cerebral aneurysm.
  • Clinical suspicion of septic embolus.
  • Uncontrolled hypertension (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/ electronic devices (pacemakers).
  • Life expectancy \< 1 year from causes other than stroke.

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2012

Estimated Enrollment :

327 Patients enrolled

Trial Details

Trial ID

NCT03767192

Start Date

January 1 2009

End Date

March 1 2012

Last Update

January 28 2019

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Erlanger Stroke Center

Chattanooga, Tennessee, United States, 37404

2

Erlangen University Clinic

Erlangen, Germany

3

Essen University Clinic

Essen, Germany

4

Heidelberg University Clinic

Heidelberg, Germany