NCT03103425

Brief Summary

The purpose of the study is to develop an emergency electroencephalogram (EEG) device, StatNet, that can be placed quickly by minimally-trained personnel and interpreted remotely for rapid identification of seizures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

June 26, 2009

Last Update Submit

March 31, 2017

Conditions

EpilepsySeizures

Keywords

New onset seizures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients Inpatients

You may qualify if:

  • Adults \> age 18
  • Epileptiform discharges present on routine EEG

You may not qualify if:

  • Open head wounds
  • Medically Unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

EpilepsySeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor in Neurology

Study Record Dates

First Submitted

June 26, 2009

First Posted

April 6, 2017

Study Start

June 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 6, 2017

Record last verified: 2017-03

Locations

US(1)