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NCT06105645Not yet recruiting

Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy

University Hospital, ToulouseClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
DIXI Medical Microdeep® Micro- Macro Depth electrodes
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
University Hospital, Toulouse
Location
Toulouse, France
Timeline & enrollment
Phase
N/A
Start date
Jan 01, 2024
End date
Apr 01, 2030
Enrollment
440 participants
Primary outcome

Contribution of fast-ripples information on freedom seizures

Summary

The main aim of this study is to evaluate the contribution of fast-ripples (FR) information
 on the neurosurgery management of patients with drug-refractory epilepsy investigated by
 Stereo-ElectroEncephaloGraphy (SEEG), as measured by freedom from disabling seizures one-year
 post-surgery.
 
 220 patients (for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid
 micro-macro electrodes and for whom fast-ripples will be assessed) distributed over 5 centres
 and 220 control patients(who will undergo an SEEG with the usual electrodes and for whom
 fast-ripples will not be assessed) distributed over 6 centres. This is a controlled,
 non-randomized, parallel plan, prospective, multicentre exploratory study.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06105645
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06105645 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Toulouse and is currently Not yet recruiting. The study focuses on Epilepsy. Target enrollment is 440 participants.

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