Drug Resistant EpilepsyNCT07911774
Edge AI Neurostimulation Controllers Versus Continuous Therapy for Drug-Resistant Focal Epilepsy
A study testing Continuous Open-Loop Neurostimulator in people with Drug Resistant Epilepsy and Focal Epilepsy, run by Lahore Medical and Dental College at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Resistant Epilepsy, Focal Epilepsy
- What is being tested?
- Continuous Open-Loop Neurostimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with refractory (drug-resistant) focal epilepsy.
- Minimum of four electroclinically documented disabling focal seizures per month despite compliance with two or more appropriately chosen antiseizure medications.
- Scheduled for clinical intracranial lead implantation (subdural grid or depth electrodes).
- Aged 18 to 65 years at the time of enrollment.
Who cannot join
- Diagnosis of primary generalized epilepsy.
- Progressive neurological disorders.
- Severe cognitive impairment.
- Active psychiatric conditions.
- Previous cranial neurostimulation implants.
- Medical contraindications to surgical implantation or continuous intracortical telemetry.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Tertiary Neurosurgical Referral Hospitals
Lahore, Punjab Province, 54570
About this study
Official title: Edge Computing Artificial Intelligence Neurostimulation Controllers Versus Standard Continuous Therapy for Drug Resistant Focal Epilepsy: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Drug Resistant Epilepsy, Focal Epilepsy
- Being tested
- Edge AI Neurostimulator Controller, Continuous Open-Loop Neurostimulator
- Keywords
- Artificial Intelligence, Edge Computing, Intracranial Electroencephalography, Neurostimulation, Machine Learning, Responsive Neurostimulation
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edge AI Neurostimulator ControllerDevice
Hardware-integrated neural processing engine executing real-time feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive electrical bursts.
Continuous Open-Loop NeurostimulatorDevice
Static, fixed-frequency continuous open-loop electrical pulse stimulation delivered regardless of underlying electrical activity.
| Study group | Role | What they receive |
|---|---|---|
| Edge Computing AI Neurostimulation | Experimental | 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. Receives: Device: Edge AI Neurostimulator Controller |
| Standard Continuous Therapy | Active comparator | Participants received continuous open-loop static neurostimulation delivering fixed-frequency electrical pulses regardless of underlying electrical activity. Receives: Device: Continuous Open-Loop Neurostimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 6 (completion of intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: Continuously across the 6-week intervention
Number of Participants with Adverse Events
Hardware-related, surgical, or neurological adverse events documented throughout the trial.
Measured: Throughout the 8-month trial duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jun 2023
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hania Aamir, Lahore Medical and Dental College
- Investigators
- Ammar Khalil, Principal investigator, University of Kotli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911774
- Sponsor's protocol ID
- UoK1117A
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edge Computing Artificial Intelligence Neurostimulation Controllers Versus Standard Continuous Therapy for Drug Resistant Focal Epilepsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07911774
- Acronym / sponsor ID
- UoK1117A
- Conditions
- Drug Resistant Epilepsy, Focal Epilepsy
- Keywords
- Artificial Intelligence, Edge Computing, Intracranial Electroencephalography, Neurostimulation, Machine Learning, Responsive Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lahore Medical and Dental CollegeUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edge Computing AI Neurostimulation | Experimental | Device: Edge AI Neurostimulator ControllerParticipants 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 Therapy | Active comparator | Device: Continuous Open-Loop NeurostimulatorParticipants received continuous open-loop static neurostimulation delivering fixed-frequency electrical pulses regardless of underlying electrical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with refractory (drug-resistant) focal epilepsy.
- Minimum of four electroclinically documented disabling focal seizures per month despite compliance with two or more appropriately chosen antiseizure medications.
- Scheduled for clinical intracranial lead implantation (subdural grid or depth electrodes).
- Aged 18 to 65 years at the time of enrollment.
Key exclusion criteria (6 listed)
- Diagnosis of primary generalized epilepsy.
- Progressive neurological disorders.
- Severe cognitive impairment.
- Active psychiatric conditions.
- Previous cranial neurostimulation implants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edge AI Neurostimulator ControllerHardware-integrated neural processing engine executing real-time feature extraction and pre-ictal spike classification from intracranial EEG, triggering adaptive electrical bursts. | Device | Edge Computing AI Neurostimulation |
| Continuous Open-Loop NeurostimulatorStatic, fixed-frequency continuous open-loop electrical pulse stimulation delivered regardless of underlying electrical activity. | Device | Standard Continuous Therapy |
Primary outcome
Monthly Clinical Focal Seizure Frequency
Time frame: Baseline and Week 6 (completion of intervention)
Number of clinical focal seizures per month, recorded continuously via automated direct intracortical telemetry logs and verified against daily patient seizure diaries
4 secondary outcomes
Microchip Pre-Ictal Classification Latency
Time frame: Continuously across the 6-week intervention
Daily Battery Drain Rate
Time frame: Continuously across the 6-week intervention
Real-Time Microchip Inference Load
Time frame: Continuously across the 6-week intervention
Number of Participants with Adverse Events
Time frame: Throughout the 8-month trial duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar Khalil principal investigator
University of Kotli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Open-Loop Neurostimulator in people with Drug Resistant Epilepsy and Focal Epilepsy, run by Lahore Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monthly Clinical Focal Seizure Frequency (time frame: Baseline and Week 6 (completion of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.