NCT03465189

Brief Summary

The investigators aim to determine the feasibility of using the Medtronic LINQ device for epilepsy diagnosis, monitoring and management. The feasibility will be determined by comparing EEG signals from the LINQ system to the gold standard clinical recordings. If seizures can be identified using the LINQ device with the same level of accuracy as adjacent scalp EEG recording electrodes, then the LINQ will be deemed feasible.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

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

First Submitted

Initial submission to the registry

March 7, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

September 10, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

March 7, 2018

Last Update Submit

October 25, 2020

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Verify feasibility of using the LINQ device for epilepsy diagnosis, monitoring and management

    Compare EEG from traditional scalp EEG to the LINQ recordings to determine if seizure activity can be accurately identified

    one week

Interventions

Medtronic LINQ DeviceDEVICE

Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).

Eligibility Criteria

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

Patients with epilepsy

You may qualify if:

  • Patients with epilepsy

You may not qualify if:

  • Women that are pregnant
  • Patients that are highly dependant on medical care
  • Patients that cannot give informed consent for themselves

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2018

First Posted

March 14, 2018

Study Start

September 10, 2018

Primary Completion

March 19, 2019

Study Completion

March 19, 2020

Last Updated

October 27, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)