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A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

Primary Purpose

Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPM sensors
SQUID sensors
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring epilepsy, MEG

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Project A: Any adult subject, who is at least eighteen (18 - 70) years old.
  • Project B: Any clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18 - 70) years old.

Exclusion Criteria:

  • ONLY applicable to Project A: have a history of neurological disorders (e.g., epilepsy, Parkinson disease, Alzheimer's disease, Autism, etc…).
  • BOTH projects: have large amounts of metal or other magnetic field producing components present in their body or external to their body close to the measurement site, which are needed for normal functioning (e.g., metal implants, pacemakers, hearing aids, braces etc.). There is no harm to the subject with metal, it disturbs the sensor reading. Dental fillings are not excluded.
  • BOTH projects: pregnant women.
  • ONLY applicable to Project A: are not comfortable lying still for the time of the recording.
  • BOTH projects: are unable to offer independent informed consent to study participation.

Sites / Locations

  • University of Colorado School of Medicine - Anschutz Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

healthy adults

Patients with intractable epilepsy

Arm Description

Any adult, who is at least eighteen (18-70) years old.

Any clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18-70) years old.

Outcomes

Primary Outcome Measures

Evoked and Induced MEG with OPM and SQUID sensors in healthy controls
compare our own and published findings related to sensory-evoked brain activity using SQUIDs with results obtained with OPMs using the same paradigm and environment.
Spontaneous MEG with OPM and SQUID sensors in patients with epilepsy
compare the clinical findings related to the localization of interictal spike activity obtained during SQUID recordings as part of our clinical program with results from OPMs data collection on the same patients.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2020
Last Updated
April 13, 2023
Sponsor
University of Colorado, Denver
Collaborators
University of Colorado, Boulder
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1. Study Identification

Unique Protocol Identification Number
NCT04515316
Brief Title
A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
Official Title
Development of A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Colorado, Boulder

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is being done to help scientists learn about the use of a device called an atomic magnetometer. The device uses sensors called optically-pumped magnetometers (OPM) which function at room temperature. This research will compare the non-invasive brain imaging application of the OPM sensors to the present SQUID-based cryogenic sensor technique used in conventional Magnetoencephalography (MEG). This study is being conducted in conjunction with the University of Colorado Boulder's Mechanical Engineering Department.
Detailed Description
Investigators at UC Boulder have an active program to develop "chip-scale" optically-pumped magnetometer (OPM) sensors, which combine high sensitivity with small size, low cost and low power operation. These sensors are an attractive alternative to superconducting quantum interference device (SQUID) magnetometers for the reasons outlined below, but remain largely unverified for use in biomagnetic applications. While considerable testing can be carried out without the use of humans, human testing is considered essential to encourage acceptance of this technology by the biomagnetic research community and more broadly by the medical community. The goal of this research is to assess and validate how well the new types of sensors perform for non-invasive brain imaging and to optimize and improve their performance for imaging. The goal is to show that these sensors are not just more economical and easier to use, but also improve signal quality. In this project specifically, OPMs can prove usefulness for telemetry, which means that long-term measurements over several days are possible, in principle. This is important, since these non-invasive imaging with these OPM sensors might be able to use replace the invasive imaging with implanted electrodes (electrocoticography (EcoG) for pre-surgical mapping of epileptic seizures. The project proposes to compare the use of OPM and SQUID sensors during recording spontaneous and evoked brain activity in healthy human volunteers as well as in patients with intractable epilepsy. Two objectives: (1) to show that the patient can move with a confined area during measurements (this is currently not possible with rigid MEG systems) and (2) to show that images can be generated with a spatial resolution equivalent to that of internal electrodes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
epilepsy, MEG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Each feasibility group is of 20 persons.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy adults
Arm Type
Experimental
Arm Description
Any adult, who is at least eighteen (18-70) years old.
Arm Title
Patients with intractable epilepsy
Arm Type
Experimental
Arm Description
Any clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18-70) years old.
Intervention Type
Device
Intervention Name(s)
OPM sensors
Intervention Description
Optically-pumped magnetometers (OPM) sensors, which are based on optical probing of alkali atoms in the vapor phase at (or slightly above) room temperature, have recently demonstrated sensitivity levels comparable with SQUID magnetometers in the laboratory. These sensors require no cooling and can potentially be fabricated at much lower cost than SQUIDs. Beginning in the late 1990s, optically-pumped magnetometers began to be used for biomagnetic applications, first for measurement of heart magnetic fields and more recently for measurement of brain fields by several groups around the world.
Intervention Type
Device
Intervention Name(s)
SQUID sensors
Intervention Description
Magnetic sensors based on superconducting quantum interference devices (SQUIDs) have been the dominant sensor in the field of magnetoencephalography since its birth in the early 1970s. SQUIDs have exceptional sensitivity to enable the detection of these very weak signals. Current FDA-approved MEG devices contain liquid helium gas in a big container that is mounted over the head of the subject
Primary Outcome Measure Information:
Title
Evoked and Induced MEG with OPM and SQUID sensors in healthy controls
Description
compare our own and published findings related to sensory-evoked brain activity using SQUIDs with results obtained with OPMs using the same paradigm and environment.
Time Frame
1 day (during the brain scan)
Title
Spontaneous MEG with OPM and SQUID sensors in patients with epilepsy
Description
compare the clinical findings related to the localization of interictal spike activity obtained during SQUID recordings as part of our clinical program with results from OPMs data collection on the same patients.
Time Frame
1 day (during the brain scan)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Project A: Any adult subject, who is at least eighteen (18 - 70) years old. Project B: Any clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18 - 70) years old. Exclusion Criteria: ONLY applicable to Project A: have a history of neurological disorders (e.g., epilepsy, Parkinson disease, Alzheimer's disease, Autism, etc…). BOTH projects: have large amounts of metal or other magnetic field producing components present in their body or external to their body close to the measurement site, which are needed for normal functioning (e.g., metal implants, pacemakers, hearing aids, braces etc.). There is no harm to the subject with metal, it disturbs the sensor reading. Dental fillings are not excluded. BOTH projects: pregnant women. ONLY applicable to Project A: are not comfortable lying still for the time of the recording. BOTH projects: are unable to offer independent informed consent to study participation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Buard, PhD
Phone
303-724-5973
Email
Isabelle.Buard@CUAnschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Lattanzio, BA
Phone
303-724-2205
Email
Lucas.Lattanzio@CUAnschutz.edu
Facility Information:
Facility Name
University of Colorado School of Medicine - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Buard, PhD
Phone
303-724-5973
Email
Isabelle.Buard@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Isabelle Buard, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

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