Using a new device to monitor epileptic seizures
Development of A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
This study is testing a new device that uses magnets to see if it can better monitor seizures in people with epilepsy compared to older methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04515316 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a room temperature atomic magnetometer system, specifically optically-pumped magnetometers (OPM), for non-invasive brain imaging in patients with epilepsy. The study will compare the performance of OPM sensors against traditional superconducting quantum interference device (SQUID) sensors used in magnetoencephalography (MEG). By conducting tests on healthy volunteers and clinical patients, the goal is to validate the OPM technology's ability to provide high-quality imaging and long-term telemetry for seizure monitoring. This could potentially replace invasive methods currently used for pre-surgical mapping of seizures.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70, particularly those referred through the clinical MEG program.
Not a fit: Patients with a history of neurological disorders or those with significant metal implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could provide a safer, non-invasive method for monitoring and diagnosing epilepsy.
How similar studies have performed: While the use of OPM sensors in biomagnetic applications is largely unverified, similar studies have shown promise in other non-invasive imaging technologies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aurora, Colorado
- University of Colorado School of Medicine - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Isabelle Buard, PhD
- Email: Isabelle.Buard@CUAnschutz.edu
- Phone: 303-724-5973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.