Wireless Ultra Long-Term EEG Recordings in Epilepsy

Status Recruiting

Clinical Trial Summary

The present study is a 13 months pre-market open-label, prospective study for confirmation of continuous performance and safety of UNEEG EpiSight solution in subjects with uncontrolled epilepsy (indicated for EEG monitoring with the Implant) in which seizures are detectable in an area of the Implant. The surgical procedure, device satisfaction, and effectiveness of the UNEEG EpiSight solution will also be evaluated during the clinical investigation.

Clinical Trial Description

The study is a multi-center study with 2-5 European sites in 2-4 countries. Each site will enrol up to 10 subjects, but total enrolment will not exceed 22 to reach 19 completers of 40 days of recording. The total recruitment period is expected to be 6 months and the total study duration is expected to be approximate 22 months (first subject first visit to last subject out). ;

Study Design

Related Conditions & MeSH terms

Epilepsy

Clinical Trial Details

NCT number	NCT05915988
Study type	Interventional
Source	UNEEG Medical A/S
Contact	Rikke Boege, BCs
Phone	+45 2712 9303
Email	studies@uneeg.com
Status	Recruiting
Phase	N/A
Start date	December 4, 2023
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04595513` - Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants	Phase 1/Phase 2
Completed	`NCT02909387` - Adapting Project UPLIFT for Blacks in Georgia	N/A
Completed	`NCT05552924` - Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients	N/A
Terminated	`NCT01668654` - Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS	Phase 3
Not yet recruiting	`NCT05068323` - Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients	N/A
Completed	`NCT03994718` - Creative Arts II Study	N/A
Recruiting	`NCT04076449` - Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
Completed	`NCT00782249` - Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Recruiting	`NCT05101161` - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes	N/A
Active, not recruiting	`NCT06034353` - Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients	N/A
Recruiting	`NCT05769933` - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Not yet recruiting	`NCT06408428` - Glioma Intraoperative MicroElectroCorticoGraphy	N/A
Not yet recruiting	`NCT05559060` - Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Completed	`NCT02646631` - Behavioral and Educational Tools to Improve Epilepsy Care	N/A
Completed	`NCT02977208` - Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use	Phase 4
Completed	`NCT02952456` - Phenomenological Approach of Epilepsy in Patients With Epilepsy
Recruiting	`NCT02539134` - TAK-935 Multiple Rising Dose Study in Healthy Participants	Phase 1
Completed	`NCT02491073` - Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)	N/A
Terminated	`NCT02757547` - Transcranial Magnetic Stimulation for Epilepsy	N/A