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

NCT00826059 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1078

Last updated 2020-02-24

No results posted yet for this study

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 hours from stroke onset.

Conditions

Interventions

DEVICE

Active Sphenopalatine Ganglion (SPG) Stimulation

SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.

DEVICE

Sham Sphenopalatine Ganglion (SPG) Stimulation

Sham SPG stimulation and standard of care. During all study periods, patients will receive Standard of Care in accordance to the general management of ischemic stroke and secondary prevention, following the guidelines of the American Heart Association/American Stroke Association and of the European Stroke Organization (ESO), including the use of antiplatelets, management of secondary stroke, dyslipidemia, hypertension, diabetes and counseling regarding smoking cessation. Off-label uses of drugs and devices should not occur during any of the study periods.

Sponsors & Collaborators

  • BrainsGate

    lead INDUSTRY

Principal Investigators

  • Eyal Shay · BrainsGate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States
  • Canada
  • Czechia
  • Denmark
  • Finland
  • France
  • Georgia
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • North Macedonia
  • Poland
  • Portugal
  • Serbia
  • Slovakia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00826059 on ClinicalTrials.gov