EpilepsyNCT07041619
Subcutaneous Intersectional Short Pulse Stimulation in Epileptic Patients
A study testing Intersection short-pulse (ISP) stimulation in people with Epilepsy, run by Semmelweis University at 1 site in Hungary.
Trial summary
A subgaleal electrode-based system combined with the novel intersectional short-pulse (ISP) stimulation was developed to enable non-invasive, high-intensity neuromodulation. ISP consists of ultra-brief, distributed pulses to maximize electric field strength in target areas while minimizing adverse effects on… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Intersection short-pulse (ISP) stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHungary
- Study dates
- 15 Nov 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18-65 years
- Patients with drug-resistant focal epilepsy who, after non-invasive or invasive EEG monitoring and neuropsychological, epilepsy protocol cranial MRI, or FDG-PET/CT or FDG-PET/MRI and/or ictal SPECT, have been declared unfit for resective epilepsy surgery by an interdisciplinary epilepsy team.
- Diagnosis of focal or idiopathic generalised epilepsy
- With antiepileptic drugs, 4 or more focal seizures per month, or frequent spike-wave activity on EEG - min 10 sec/hour.
- A patient who is fit to care for the wound and whose home environment this in terms of compliance and cleanliness
Who cannot join
- subjects under 18 years old
- If the patient is suitable for resective surgery or if there are questions about the patient's suitability for resective surgery of autoimmune aetiology
- Progressive brain lesions on MRI or a serious internal organ disease or coagulopathy considered serious by your doctor
- Subjects who have an electrical energy transmitting implant implanted in the brain or other organ(s), including pacemakers, intracardiac defibrillators and any device meeting this definition
- Pregnancy. Pregnancy should be checked by a pregnancy test for all women of childbearing potential
- Previous traumatic brain and skull injury, stroke are not exclusionary, but in all such cases the examining physician and the Neunos technical support team should be consulted
- The presence of metal implants is generally considered contraindicated. In all such cases, the investigating physician or the Neunos technical support team should be consulted
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University Neurosurgery and Neurointerventional Clinic
Budapest, 1145
Principal Investigator, +3614679301, titkarsag.amerikaiut@semmelweis.hu
About this study
Official title: Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients
A subgaleal electrode-based system combined with the novel intersectional short-pulse (ISP) stimulation was developed to enable non-invasive, high-intensity neuromodulation. ISP consists of ultra-brief, distributed pulses to maximize electric field strength in target areas while minimizing adverse effects on non-target tissues. Early preclinical studies demonstrate its efficacy in disrupting pathological oscillations and reducing seizures in animal models. This study investigates how targeted electrical brain stimulation by ISP stimulation impacts brain activity in epilepsy patients. The research aims to determine if ISP stimulation delivered via electrodes placed outside and under the scalp can safely and effectively reduce seizure frequency and intensity. Participants include epilepsy patients who haven't responded adequately to medication and aren't eligible for surgery. By precisely tuning stimulation parameters and timing stimulation to specific seizure patterns detected by EEG monitoring, the study seeks to optimize this technique for therapeutic use. The goal is to establish safety and feasibility of this minimally invasive stimulation approach, as well as to achieve preliminary efficacy data thorugh the reduction of seizure durations.
Read the detailed description
This clinical trial focuses on evaluating the safety, tolerability, and effectiveness of Intersectional Short Pulse (ISP) electrical stimulation in epilepsy patients. As a secondary outcome, the efficacy of ISP for reducing epileptic seizure duration and severity is also assessed. The ISP method utilizes electrodes implanted subcutaneously beneath the scalp, guided by MRI imaging for precise targeting.
The trial encompasses the following phases:
- Obtaining informed consents
- MRI scans are conducted to personalize electrode placement based on head anatomy.
- Electrodes are surgically implanted under general anesthesia.
- Following implantation, continuous EEG monitoring captures baseline seizure activity.
- Patients participate in stimulation tests to confirm tolerable ISP parameters.
- Patients participate in stimulation tests to confirm the feasibility of ISP stimulation triggered by epileptic seizures. An advanced seizure-detection algorithm (with close supervision) triggers stimulation to target seizures at their onset either, aiming to prevent their progression.
- Safety and tolerability are continuously assessed through clinical observations and participant feedback.
- Possible acute effects of ISP stimulation (i.e. reduction of seizure severity and duration or stopping seizures entirely) are also recorded as secondary outcomes.
- After concluding data recording, electrodes are explanted and the patients are emitted.
- Follow-up evaluations ensure long-term safety and monitor ongoing seizure activity post-treatment.
- Data processing: EEG data is rigorously analyzed, comparing seizure duration, severity and frequency before and after stimulation.
- Conditions
- Epilepsy
- Being tested
- Intersection short-pulse (ISP) stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intersection short-pulse (ISP) stimulationDevice
The intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Stimulation of pathological epileptiform brain activity | Experimental | Not described Receives: Device: Intersection short-pulse (ISP) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Automatically Detected Seizures Successfully Treated with Closed-loop Subgaleal ISP Stimulation [Feasibility]
Intervention delivery rate (success rate of demonstrating the deliverability of the method as designed in the patient population, i.e. automatic seizure detection followed by ictal stimulation by subgaleal ISP stimulation)
Measured: From enrollment to the end of treatment at maximum 12 weeks
Incidence and Severity of Treatment-Emergent Adverse Events of Subgaleal ISP stimulation [Safety]
Frequency (number) and severity (graded mild, moderate, severe) of all adverse events experienced by each patient during the treatment period.
Measured: From enrollment to the end of treatment at maximum 12 weeks
Level of Subjective Discomfort associated with of subgaleal ISP stimulation [Tolerability]
Patient-reported subjective perception of stimulation intensity recorded on a Visual Analog Scale (VAS), ranging from 0 (no discomfort) to 10 (maximum discomfort). Higher scores indicate greater discomfort and worse tolerability.
Measured: From enrollment to the end of treatment at maximum 12 weeks
Secondary outcomes (1)
Efficacy of seizure termination by subgaleal ISP stimulation
Percent decrease in average seizure duration between stimulated (i.e. treated) and non-stimulated (i.e. control) seizures
Measured: From enrollment to the end of treatment at maximum 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Nov 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Collaborators
- Neunos ZRt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041619
- Sponsor's protocol ID
- OGYÉI/9674/2021
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Brain Activity as a Function of Scalp and Subcutaneous Electrical Stimulation Parameters in Epileptic Patients
- ClinicalTrials.gov ID
- NCT07041619
- Acronym / sponsor ID
- OGYÉI/9674/2021
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Collaborators
- Neunos ZRt
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
A subgaleal electrode-based system combined with the novel intersectional short-pulse (ISP) stimulation was developed to enable non-invasive, high-intensity neuromodulation. ISP consists of ultra-brief, distributed pulses to maximize electric field strength in target areas while minimizing adverse effects on non-target tissues. Early preclinical studies demonstrate its efficacy in disrupting pathological oscillations and reducing seizures in animal models. This study investigates how targeted electrical brain stimulation by ISP stimulation impacts brain activity in epilepsy patients. The research aims to determine if ISP stimulation delivered via electrodes placed outside and under the scalp can safely and effectively reduce seizure frequency and intensity. Participants include epilepsy patients who haven't responded adequately to medication and aren't eligible for surgery. By precisely tuning stimulation parameters and timing stimulation to specific seizure patterns detected by EEG monitoring, the study seeks to optimize this technique for therapeutic use. The goal is to establish safety and feasibility of this minimally invasive stimulation approach, as well as to achieve preliminary efficacy data thorugh the reduction of seizure durations.
Detailed description
This clinical trial focuses on evaluating the safety, tolerability, and effectiveness of Intersectional Short Pulse (ISP) electrical stimulation in epilepsy patients. As a secondary outcome, the efficacy of ISP for reducing epileptic seizure duration and severity is also assessed. The ISP method utilizes electrodes implanted subcutaneously beneath the scalp, guided by MRI imaging for precise targeting.
The trial encompasses the following phases:
- Obtaining informed consents
- MRI scans are conducted to personalize electrode placement based on head anatomy.
- Electrodes are surgically implanted under general anesthesia.
- Following implantation, continuous EEG monitoring captures baseline seizure activity.
- Patients participate in stimulation tests to confirm tolerable ISP parameters.
- Patients participate in stimulation tests to confirm the feasibility of ISP stimulation triggered by epileptic seizures. An advanced seizure-detection algorithm (with close supervision) triggers stimulation to target seizures at their onset either, aiming to prevent their progression.
- Safety and tolerability are continuously assessed through clinical observations and participant feedback.
- Possible acute effects of ISP stimulation (i.e. reduction of seizure severity and duration or stopping seizures entirely) are also recorded as secondary outcomes.
- After concluding data recording, electrodes are explanted and the patients are emitted.
- Follow-up evaluations ensure long-term safety and monitor ongoing seizure activity post-treatment.
- Data processing: EEG data is rigorously analyzed, comparing seizure duration, severity and frequency before and after stimulation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Stimulation of pathological epileptiform brain activity | Experimental | Device: Intersection short-pulse (ISP) stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18-65 years
- Patients with drug-resistant focal epilepsy who, after non-invasive or invasive EEG monitoring and neuropsychological, epilepsy protocol cranial MRI, or FDG-PET/CT or FDG-PET/MRI and/or ictal SPECT, have been declared unfit for resective epilepsy surgery by an interdisciplinary epilepsy team.
- Diagnosis of focal or idiopathic generalised epilepsy
- With antiepileptic drugs, 4 or more focal seizures per month, or frequent spike-wave activity on EEG - min 10 sec/hour.
- A patient who is fit to care for the wound and whose home environment this in terms of compliance and cleanliness
Key exclusion criteria (7 listed)
- subjects under 18 years old
- If the patient is suitable for resective surgery or if there are questions about the patient's suitability for resective surgery of autoimmune aetiology
- Progressive brain lesions on MRI or a serious internal organ disease or coagulopathy considered serious by your doctor
- Subjects who have an electrical energy transmitting implant implanted in the brain or other organ(s), including pacemakers, intracardiac defibrillators and any device meeting this definition
- Pregnancy. Pregnancy should be checked by a pregnancy test for all women of childbearing potential
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 |
|---|---|---|
| Intersection short-pulse (ISP) stimulationThe intervention aims to terminate pathological brain oscillations (i.e. epileptiform activity) in patients. | Device | Single Arm: Stimulation of pathological epileptiform brain activity |
Primary outcome
Percentage of Automatically Detected Seizures Successfully Treated with Closed-loop Subgaleal ISP Stimulation [Feasibility]
Time frame: From enrollment to the end of treatment at maximum 12 weeks
Intervention delivery rate (success rate of demonstrating the deliverability of the method as designed in the patient population, i.e. automatic seizure detection followed by ictal stimulation by subgaleal ISP stimulation)
Incidence and Severity of Treatment-Emergent Adverse Events of Subgaleal ISP stimulation [Safety]
Time frame: From enrollment to the end of treatment at maximum 12 weeks
Frequency (number) and severity (graded mild, moderate, severe) of all adverse events experienced by each patient during the treatment period.
Level of Subjective Discomfort associated with of subgaleal ISP stimulation [Tolerability]
Time frame: From enrollment to the end of treatment at maximum 12 weeks
Patient-reported subjective perception of stimulation intensity recorded on a Visual Analog Scale (VAS), ranging from 0 (no discomfort) to 10 (maximum discomfort). Higher scores indicate greater discomfort and worse tolerability.
1 secondary outcome
Efficacy of seizure termination by subgaleal ISP stimulation
Time frame: From enrollment to the end of treatment at maximum 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
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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.
Semmelweis University Neurosurgery and Neurointerventional Clinic
Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intersection short-pulse (ISP) stimulation in people with Epilepsy, run by Semmelweis University at 1 site in Hungary.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Jul 2025. 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 Hungary. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Automatically Detected Seizures Successfully Treated with Closed-loop Subgaleal ISP Stimulation [Feasibility] (time frame: From enrollment to the end of treatment at maximum 12 weeks). The study lists 3 primary outcomes in all. 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 Jul 2025.