NCT07911774
Edge AI Neurostimulation Controllers Versus Continuous Therapy for Drug-Resistant Focal Epilepsy
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Monthly Clinical Focal Seizure Frequency
Timeframe: Baseline and Week 6 (completion of intervention)
Secondary (4)
Microchip Pre-Ictal Classification Latency
Daily Battery Drain Rate
Real-Time Microchip Inference Load
Number of Participants with Adverse Events
Arms and interventions
Edge Computing AI NeurostimulationExperimental
Participants received an implantable neurostimulator running local edge computing machine learning algorithms to classify pre-ictal spikes from intracortical EEG in real time, delivering adaptive targeted electrical impulse bursts.
Standard Continuous TherapyActive comparator
Participants received continuous open-loop static neurostimulation delivering fixed-frequency electrical pulses regardless of underlying electrical activity.
Devices: Edge AI Neurostimulator Controller, Continuous Open-Loop Neurostimulator
Sites
1 site in 1 country
- Tertiary Neurosurgical Referral HospitalsLahore, Punjab Province, Pakistan