An interventional study of Edge AI Neurostimulator Controller and Continuous Open-Loop Neurostimulator in Drug Resistant Epilepsy and Focal Epilepsy, sponsored by Lahore Medical and Dental College. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Lahore Medical and Dental College · Not applicable, Interventional, and Treatment
Drug-resistant focal epilepsy remains a major therapeutic challenge. Conventional neurostimulators rely on static, continuous open-loop stimulation or low-bandwidth reactive loops that suffer from classification latency or high battery consumption. This prospective, double-blind, randomized controlled trial evaluates whether hardware-integrated edge computing artificial intelligence (AI) neurostimulators demonstrate superior seizure reduction, lower processing latency, and reduced battery drain compared to standard continuous neurostimulation therapy over a 6-week intervention period.
Eighty adult patients with drug-resistant focal epilepsy undergoing intracranial lead implantation across tertiary referral centers were randomized 1:1 post-implantation into two parallel groups: Edge Computing AI Neurostimulation: Received localized on-hardware machine learning feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive targeted high-frequency electrical impulse bursts. Standard Continuous Therapy: Received conventional fixed-frequency, open-loop electrical neurostimulation. The trial evaluated clinical seizure frequency tracked via direct intracortical telemetry logs validated by daily patient diaries, as well as operational hardware metrics including microchip classification latency, real-time inference execution loads, and daily milliampere-hour battery consumption over 6 weeks.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's enrollment of 80 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →This is the only study on the registry with Lahore Medical and Dental College as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Edge AI Neurostimulator Controller
Participants received continuous open-loop static neurostimulation delivering fixed-frequency electrical pulses regardless of underlying electrical activity.
Device: Continuous Open-Loop Neurostimulator
Hardware-integrated neural processing engine executing real-time feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive electrical bursts.
Static, fixed-frequency continuous open-loop electrical pulse stimulation delivered regardless of underlying electrical activity.
Monthly Clinical Focal Seizure Frequency
Number of clinical focal seizures per month, recorded continuously via automated direct intracortical telemetry logs and verified against daily patient seizure diaries
Time frame: Baseline and Week 6 (completion of intervention)
Microchip Pre-Ictal Classification Latency
Local on-hardware signal processing and classification response time measured in milliseconds (ms) from raw intracranial EEG pattern identification to trigger execution.
Time frame: Continuously across the 6-week intervention
Daily Battery Drain Rate
Average daily battery consumption rate measured in milliampere-hours per day (mAh/day) from device telemetry logs.
Time frame: Continuously across the 6-week intervention
Real-Time Microchip Inference Load
Percentage of microchip processing capacity utilized during real-time on-device machine learning execution.
Time frame: Continuously across the 6-week intervention
Number of Participants with Adverse Events
Hardware-related, surgical, or neurological adverse events documented throughout the trial.
Time frame: Throughout the 8-month trial duration
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Jan 2024, 7 months.
Of 90 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21. This study's 7 months is below that.
Counting every sponsor, half of 102 studies reached it within 34 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.