Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)
Recruiting · NCT05944692 · Observational (researchers observe without assigning treatment) · Lead sponsor: CREmedical
View the official record on ClinicalTrials.gov →Interventions studied
Tripolar electroencephalography
What this trial is about
Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.
Who can take part
Age range
6 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Pediatric (BCH): Age ≥ 6 years and \< 18 years
- Adult (BNI): Age ≥ 18 years
- Able to provide written informed consent or have a legally authorized representative able to provide consent; pediatric patients to provide assent when appropriate
- Scheduled for routine outpatient EEG for clinical diagnosis
- Able to participate in a post-EEG telemedicine video visit
- Clinical diagnosis of epilepsy with epileptiform discharges on prior routine EEG
- Scheduled for inpatient video-EEG monitoring for clinical diagnosis
- MRI of brain available for co-registration
- Confirmed diagnosis of focal epilepsy by prior video-EEG monitoring interpreted by board-certified epileptologist or clinical neurophysiologist
- Scheduled for inpatient video-EEG monitoring with intracranial stereo-EEG electrodes for epilepsy presurgical evaluation
- MRI of brain available for co-registration
Exclusion criteria
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data
- Any clinical suspicion of prion disease
- History of allergy or adverse reaction to EEG electrode paste or gel
- Scalp lesions or infections
- Severe intellectual disability or behavioral disorders with inability to cooperate with EEG application or recording
Where it is running
2 locations listed across 2 US states.
- Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center - Phoenix, Arizona, United States
- Boston Children's Hospital - Boston, Massachusetts, United States