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Augmenting Cerebral Blood Flow to Preserve the Penumbra Trial

NCT04014621 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-30

No results posted yet for this study

Summary

The primary objective of the study is to demonstrate that SPG (Sphenopalatine Ganglion) stimulation started within 6 hours from stroke onset slows the expansion of the infarct core volume in acute ischemic stroke.

Conditions

Interventions

DEVICE

SPG stimulation

The BrainsGate Ischemic Stroke System (ISS) consists of an implantable neurostimulator designed to deliver electrical stimulation to the sphenopalatine ganglion (SPG) and/or nerves within the greater palatine canal and pterygopalatine fossa.

Sponsors & Collaborators

  • BrainsGate

    lead INDUSTRY

Principal Investigators

  • Yoram Slolberg, Dr. · BrainsGate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-20
Primary Completion
2021-01-31
Completion
2021-04-30

Countries

  • Georgia

Study Locations

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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 NCT04014621 on ClinicalTrials.gov