Seizure Detection and Warning System for Epilepsy Patients
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 13-001007
- Jacksonville, Florida: 13-001007
NCT ID: NCT01874600
Sponsor Protocol Number: BS-0421
About this study
The seizure detection and warning system is an ambulatory system designed to monitor and analyze EMG data to detect the onset of GTC seizures and to provide a warning signal to alert caregivers that a seizure is occurring.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- Have a history of generalized tonic-clonic seizures, either primary GTC or partial onset seizures with 2nd generalization.
- Be admitted to a hospital for routine vEEG monitoring related to seizures.
- Be ages 2-99.
- Have an upper arm circumference which is adequate for proper fit of the EMG monitor or the monitor with arm adapter (approximately 16 cm).
- Be able to be discharged to a home with electrical power supply.
- Be able to be discharged to a home where internet service via phone, broadband, satellite or cellular phone service can be provided.
- If female and of childbearing potential, have negative pregnancy test.
- Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
- Subject and/or Primary Caregiver must be competent to follow all study procedures.
- Able to read, speak, and understand English.
- Does not have a documented history of generalized seizures.
- Has not had a GTC seizure within the last year AND is not expected to have a reduction of anti-epileptic drugs during their hospital admission.
- Intracranial EEG electrodes are being used
- Upper arm circumference not adequate for proper fit of the EMG monitor even if the arm adapter is used (less than approximately 16cm).
- If female, is pregnant.
- Subject or Caregiver are unable to provide consent.
- Subject or Caregiver not competent to follow home study procedures.
- Homeless or home without power supply.
- Resides in a home where internet service via phone, broadband, satellite or cellular phone service cannot be provided.
- Subject or Caregiver is unable to read, speak, or understand English.
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.