EpilepsyNCT04515316
A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
A study testing OPM sensors and SQUID sensors in people with Epilepsy, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- OPM sensors and SQUID sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Colorado School of Medicine - Anschutz Medical Campus
Aurora, Colorado, 80045
Isabelle Buard, PhD, 303-724-5973, Isabelle.Buard@cuanschutz.edu
Isabelle Buard, PhD
About this study
Official title: Development of A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- OPM sensors, SQUID sensors
- Keywords
- epilepsy, MEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPM sensorsDevice
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 sensorsDevice
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
| Study group | Role | What they receive |
|---|---|---|
| healthy adults | Experimental | Any adult, who is at least eighteen (18-70) years old. Receives: 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. Receives: Device: OPM sensors; Device: SQUID sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day (during the brain scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start1 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Each feasibility group is of 20 persons.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Boulder
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515316
- Sponsor's protocol ID
- 19-2363
- Status last verified
- May 2024
- First submitted
- 6 Apr 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of A Room Temperature Atomic Magnetrode System for Telemetry of Epileptic Seizures
- ClinicalTrials.gov ID
- NCT04515316
- Acronym / sponsor ID
- 19-2363
- Conditions
- Epilepsy
- Keywords
- epilepsy, MEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado, Boulder
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each feasibility group is of 20 persons.
| Arm | Type | Receives |
|---|---|---|
| healthy adults | Experimental | Device: OPM sensors, Device: SQUID sensorsAny adult, who is at least eighteen (18-70) years old. |
| Patients with intractable epilepsy | Experimental | Device: OPM sensors, Device: SQUID sensorsAny clinical patient referred to us via the clinical MEG program, and who is at least eighteen (18-70) years old. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPM sensorsOptically-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. | Device | Patients with intractable epilepsy, healthy adults |
| SQUID sensorsMagnetic 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 | Device | Patients with intractable epilepsy, healthy adults |
Primary outcome
Evoked and Induced MEG with OPM and SQUID sensors in healthy controls
Time frame: 1 day (during the brain scan)
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
Time frame: 1 day (during the brain scan)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPM sensors and SQUID sensors in people with Epilepsy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Buard, PhD (303-724-5973, Isabelle.Buard@CUAnschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoked and Induced MEG with OPM and SQUID sensors in healthy controls (time frame: 1 day (during the brain scan)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.