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

NCT03767192 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 327

Last updated 2019-01-28

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

  • Acute Ischemic Stroke

Interventions

DEVICE

Active Stimulation

SPG stimulation and standard of care

DEVICE

Sham Stimulation

Sham SPG stimulation and standard of care

Sponsors & Collaborators

  • BrainsGate

    lead INDUSTRY

Principal Investigators

  • Eyal Shay · BrainsGate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-01-31
Completion
2012-03-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Spain

Study Locations

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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 NCT03767192 on ClinicalTrials.gov