A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures

NCT04515316 | Recruiting

• 1 other identifier: 19-2363
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

epilepsy; MEG

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day (during the brain scan)

• 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.

  1 day (during the brain scan)

Study Arms (2)

healthy adults

EXPERIMENTAL

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

Device: OPM sensors; Device: SQUID sensors

Patients with intractable epilepsy

EXPERIMENTAL

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

Device: OPM sensors; Device: SQUID sensors

Interventions

OPM sensors DEVICE

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.

Patients with intractable epilepsy; healthy adults

SQUID sensors DEVICE

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

Patients with intractable epilepsy; healthy adults

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado School of Medicine - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Isabelle Buard, PhD

CONTACT

303-724-5973; Isabelle.Buard@CUAnschutz.edu

Lucas Lattanzio, BA

CONTACT

303-724-2205; Lucas.Lattanzio@CUAnschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each feasibility group is of 20 persons.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: August 17, 2020
• Study Start: March 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)