Clinical trial NCT04515316: 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
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
MEG
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2020-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Each feasibility group is of 20 persons.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Evoked and Induced MEG with OPM and SQUID sensors in healthy controls
timeFrame: 1 day (during the brain scan)
measure: Spontaneous MEG with OPM and SQUID sensors in patients with epilepsy
timeFrame: 1 day (during the brain scan)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine - Anschutz Medical Campus
state: Colorado
Study officials:
References: