NCT02946151

Brief Summary

The study is a two-phase study, which aims to explore the uses of a novel electrode type in detecting epileptic seizures. The electrode is designed for subcutaneous implantation with long-term monitoring in mind.

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 not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

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

October 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2.2 years

First QC Date

October 19, 2016

Last Update Submit

May 6, 2019

Conditions

Temporal Lobe Epilepsy

Keywords

EpilepsySeizure monitoringElectroencephalography

Outcome Measures

Primary Outcomes (3)

  • Seizure comparison

    Qualitative comparison of patient-recorded seizures and EEGgraphical seizures

    24 months

  • Adverse events

    Descriptive account of device related adverse events

    24 months

  • Compliance

    Descriptive account of compliance in use of the investigational device

    24 months

Study Arms (1)

Implantation

EXPERIMENTAL

Implantation of a subcutaneous electrode and connection to the external logging device

Device: UNEEG implantable EEG electrode and data storage device

Interventions

UNEEG implantable EEG electrode and data storage deviceDEVICE

The implantable EEG electrode will be implanted subcutaneously in the relevant temporal region by a certified neurosurgeon. The EEGgraphical data recorded will be transmitted transcutaneously to the data storage device via an inductive link, providing continuous data on brain activity.

Implantation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Semiology of some seizures compatible with mesial temporal lobe involvement.
  • Paraclinical findings supporting mesial temporal seizure focus. Such proof may consist of:
  • previous EEG recording interpreted as compatible with mesial temporal involvement OR
  • radiological findings demonstrating pathology in the mesial temporal area (CT, MRI, FDG-PET or SPECT).
  • Age 18-90.
  • Current seizure frequency (fulfilling criteria 1) of more than one per week to be eligible to EMU admission or 1 per month for direct enrollment to home monitoring (by own account).
  • Available for the duration of the study (6 months from screening).

You may not qualify if:

  • Known disorder of hemostasis.
  • Daily or frequent (more than 2 days per week) treatment with any drugs of the following types:
  • antiplatelets
  • anticoagulants
  • chemotherapeutics
  • non-steroid anti-inflammatory drugs (NSAID)
  • omega 3 fatty acids (fish oil)
  • Skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
  • Scheduled facial or cranial surgery within 6 months from enrollment.
  • Active deep brain stimulation device.
  • Presence of implanted ICD pacemaker, cochlear implant or other active implants.
  • Planned transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) in the duration of the study.
  • Presence of any implanted device at the proposed site of implantation.
  • Known allergy towards any material that is part of the investigational device.
  • Females of childbearing potential who are pregnant, intend to become pregnant, or are not using adequate contraceptive methods throughout the study.
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zealand University hospital

Roskilde, 4000, Denmark

Location

Related Publications (1)

  • Gangstad SW, Mikkelsen KB, Kidmose P, Tabar YR, Weisdorf S, Lauritzen MH, Hemmsen MC, Hansen LK, Kjaer TW, Duun-Henriksen J. Automatic sleep stage classification based on subcutaneous EEG in patients with epilepsy. Biomed Eng Online. 2019 Oct 30;18(1):106. doi: 10.1186/s12938-019-0725-3.

    PMID: 31666082DERIVED

MeSH Terms

Conditions

Epilepsy, Temporal LobeEpilepsy

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Officials

  • Troels Kjær, Professor

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 27, 2016

Study Start

November 1, 2016

Primary Completion

January 23, 2019

Study Completion

February 11, 2019

Last Updated

May 8, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)