Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT04515316

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

OPM sensors

SQUID sensors

Study Details

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

Study ID

NCT04515316

Start date

Mar 1, 2021

Status verified date

May, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: healthy adults

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

experimental: Patients with intractable epilepsy

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

Interventions

OPM sensors

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.

SQUID sensors

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

  • Evoked and Induced MEG with OPM and SQUID sensors in healthy controls [ Time Frame: 1 day (during the brain scan) ]
  • Spontaneous MEG with OPM and SQUID sensors in patients with epilepsy [ Time Frame: 1 day (during the brain scan) ]

Central Contacts and Locations

Central contacts

Isabelle Buard, PhD

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

Lucas Lattanzio, BA

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

Locations

University of Colorado School of Medicine - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Isabelle Buard, PhD

303-724-5973Isabelle.Buard@cuanschutz.edu

Principal Investigator:

Isabelle Buard, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 16, 2024

Last verified

May, 2024

Keywords

  • epilepsy
  • MEG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-16.