Autoimmune EpilepsyNCT05627661
Wearable Devices to Monitor Seizures in Autoimmune Epilepsy
A study testing Biosensor in people with Autoimmune Epilepsy and Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Epilepsy, Healthy
- What is being tested?
- Biosensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2022to 22 Nov 2023
- 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
- Patients diagnosed with or suspected of having autoimmune epilepsy.
- Normal controls - cognitively normal subjects without epilepsy
Who cannot join
- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Multiple Seizure Types With Wearable Devices
The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.
- Conditions
- Autoimmune Epilepsy, Healthy
- Being tested
- Biosensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiosensorDevice
Noninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune Epilepsy with Biosensors | Experimental | Subjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period. Receives: Device: Biosensor |
| Healthy Controls with Biosensors | Active comparator | Neurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period. Receives: Device: Biosensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of high-quality physiological signals
Total number of high-quality physiological signals recorded by biosensors
Measured: 10 days
Number of Reproducible changes in physiological biosignals
Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start27 Oct 2022
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin H. Brinkmann, Mayo Clinic
- Investigators
- Benjamin Brinkmann, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627661
- Sponsor's protocol ID
- 22-006702
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2022
- Last updated
- 26 Nov 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Multiple Seizure Types With Wearable Devices
- ClinicalTrials.gov ID
- NCT05627661
- Acronym / sponsor ID
- 22-006702
- Conditions
- Autoimmune Epilepsy, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 25 Nov 2022 (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.
The purpose of this research is to search for reproducible changes in a wide range of physical signals, including heart rate, muscle tone and activity and EEG before and at the onset of seizures in patients with epilepsy.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autoimmune Epilepsy with Biosensors | Experimental | Device: BiosensorSubjects with suspected autoimmune epilepsy will wear biosensors on wrist or upper arm during the at home monitoring period. |
| Healthy Controls with Biosensors | Active comparator | Device: BiosensorNeurologically normal adult healthy controls will wear biosensors on wrist or upper arm during the at home monitoring period. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with or suspected of having autoimmune epilepsy.
- Normal controls - cognitively normal subjects without epilepsy
Key exclusion criteria (1 listed)
- Cognitive or psychiatric condition rendering patient unable to cooperate with data collection or manage and recharge smart watch and tablet computer devices. Presence of open or healing wounds near monitoring sites (infection risk).
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 |
|---|---|---|
| BiosensorNoninvasive wearable biosensor device worn on the primary affected wrist or upper arm for as much time as is feasible for 7-10 days | Device | Autoimmune Epilepsy with Biosensors, Healthy Controls with Biosensors |
Primary outcome
Number of high-quality physiological signals
Time frame: 10 days
Total number of high-quality physiological signals recorded by biosensors
Number of Reproducible changes in physiological biosignals
Time frame: 10 days
Identification of reproducible changes in one or more physiological biosignals at onset of video and/or EEG-identified seizures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Benjamin Brinkmann, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biosensor in people with Autoimmune Epilepsy and Healthy, run by Mayo Clinic 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 1 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: finished, as of the sponsor's last update on 26 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of high-quality physiological signals (time frame: 10 days). 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 26 Nov 2024.