Other Forms of Epilepsy, Treatment ResistantNCT05825274
TDCs to Treat Drug-resistant Epilepsy
A study testing Active Cathodal tDCS in people with Other Forms of Epilepsy, Treatment Resistant, run by Spanish Foundation for Neurometrics Development at 1 site in United Kingdom.
Trial summary
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide. Modern epidemiological studies indicate that the global annualized cumulative incidence ranges between 42.8 and 67.8 new cases per 100,000 people each year, with figures scaling up to 139… Read more about this study
- Who is it for?
- Ages 18 to 120 monthsHealthy volunteers can take part
- Conditions the study is for
- Other Forms of Epilepsy, Treatment Resistant
- What is being tested?
- Active Cathodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2017to 28 Dec 2017
- 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 120 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients aged between 4 and 6 years at the time of screening.
- Formally diagnosed with drug-resistant focal epilepsy according to the International League Against Epilepsy (ILAE) criteria (failure of adequate trials of two or more tolerated, appropriately chosen, and appropriately used antiepileptic drug regimens).
- Experiencing a baseline frequency of at least 3 clinical seizures per week, documented via a reliable prospective seizure diary kept by parents or caregivers.
- Patients whose legal guardians are willing and able to provide written informed consent, and patients who can provide assent when age-appropriate.
Who cannot join
- Presence of metallic implants in the brain or skull (e.g., surgical clips, cochlear implants) near the site of electrode placement.
- History of severe cardiac arrhythmias, unstable cardiovascular disease, or baseline pacemaker dependent, which may compromise safety during Heart Rate Variability (HRV) monitoring.
- Progressive neurological disorders, neurodegenerative diseases, or active brain tumors.
- Recent changes in antiepileptic drug (AED) dosages or types within the 4 weeks prior to baseline screening.
- Any active skin lesions, inflammation, or structural cranial abnormalities at the target electrode site that prevent safe application of the tDCS pads.
- Current participation in another clinical trial involving investigational drugs or neurostimulation devices.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide. Modern epidemiological studies indicate that the global annualized cumulative incidence ranges between 42.8 and 67.8 new cases per 100,000 people each year, with figures scaling up to 139 per 100,000 in low- and middle-income regions. A community-based study conducted in France concluded that up to 22.5% of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial dysfunction, and a reduced quality of life.
Read the detailed description
The International League Against Epilepsy (ILAE) defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients is the drive to develop different approaches in order to offer alternatives for control.In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarization shifts, an enhanced probability of high-frequency and hypersynchronous activity of small neuronal networks, and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal connections.Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repeatedly, it generates long-lasting cortical excitability shifts through mechanisms resembling long-term depression (LTD). In this study, cathodal tDCS (c-tDCS) is utilized to apply a hyperpolarizing current directly over the primary epileptogenic focus, aiming to suppress pathological network activity and reduce seizure frequency in pediatric patients.
- Being tested
- Active Cathodal tDCS
- Keywords
- Drug-resistant epilepsy, tDCS
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cathodal tDCSDevice
Also called Brain Noninvasive Electrical Stimulation, tDCS, Placebo
Active cathodal stimulation delivered at twice-weekly intervals. Each therapeutic session lasts 30 minutes, with the cathode electrode localized over the patient-specific epileptic focus to reduce cortical hyperexcitability.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Active c-tDCS Group | Experimental | A cohort of 50 pediatric patients with drug-resistant focal epilepsy experiencing at least 3 seizures per week. Participants receive active cathodal transcranial direct current stimulation (c-tDCS) targeted over the primary epileptogenic focus. Digital electroencephalography (EEG) utilizing a 19-channel montage is performed immediately before and after the intervention period. Treatment efficacy on psychosocial outcomes is evaluated using the Quality of Life in Epilepsy Inventory for Adolescents/Children (QOLIE-31) questionnaire. Receives: Device: Active Cathodal tDCS |
| Device: Active Cathodal tDCS | Experimental | Active cathodal stimulation delivered at twice-weekly intervals. Each therapeutic session lasts 35 minutes, with the cathode electrode localized over the patient-specific epileptic focus to reduce cortical hyperexcitability. Receives: Device: Active Cathodal tDCS |
| : Placebo Comparator: Sham tDCS Group | Sham comparator | A control cohort of 50 pediatric patients with drug-resistant focal epilepsy experiencing at least 3 seizures per week. Participants undergo the identical procedural, preparation, and 19-channel EEG monitoring protocols before and after the intervention as the experimental group, but receive inactive sham (placebo) stimulation. Quality of life tracking is assessed via the QOLIE-31 questionnaire. Receives: Device: Active Cathodal tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Seizure Frequency
Assessment of patient-reported quality of life. The total score ranges from 0 to 100 points, where higher scores indicate a better quality of life. This scale will be evaluated as a single independent outcome measure. BaselineF LIFE IN EPILEPSY - QOLIE-31.
Measured: Baseline and Week 24
Heart Rate Variability (HRV) Changes
To evaluate cardiac safety, specific parameters will be extracted and analyzed from standard 12-lead ECG recordings. The assessed components will explicitly include: Heart Rate (bpm), PR interval (ms), QRS complex duration (ms), QT interval (ms), and corrected QT interval (QTc, ms) using Fridericia's formula
Measured: Baseline and Week 24
Change from Baseline in Seizure Frequency
Evaluation of efficacy based on the change in seizure frequency. This metric will assess the number of observable seizures per 28-day period (seizures/28 days), as documented by patient/caregiver diaries, comparing the baseline phase to the final 4 weeks of the treatment period (up to Week 24).
Measured: Baseline and Week 24
Change from Baseline in Vital Signs
Evaluation of clinical safety through the assessment of vital signs. The specific metrics to be evaluated independently as continuous variables include: Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Heart Rate (beats per minute), and Body Temperature (°C).
Measured: Baseline and Week 24
Secondary outcomes (1)
Change in Brain Electrical Activity via Electroencephalogram (EEG)
Neurophysiological changes and treatment efficacy will be quantified using quantitative EEG (qEEG) analysis. The evaluation will precisely assess changes in absolute and relative power spectral density across the following frequency bandwidths: Delta (0.5-4 Hz), Theta (4-8 Hz), Alpha (8-12 Hz), and Beta (12-30 Hz). Additionally, the hourly frequency of epileptiform discharges (spikes and sharp waves) will be quantified to assess seizure susceptibility.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2017
- Primary completion1 Oct 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Other Forms of Epilepsy, Treatment ResistantStudies 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
- Model description
- Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moises Aguilar Domingo, Spanish Foundation for Neurometrics Development
- Investigators
- Fernando Vargas Torgal, MD, Study chair, FSI, Fundacion Salud Infantil Elxe (Alcante)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825274
- Sponsor's protocol ID
- RefEpTDCs
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2017
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: biogdata4brain.com is the database where our foundation recorda all the clinical data of our assays
Publications
Cao Y, Cheung NA, Giustini D, LeDue J, Murphy TH. Scholar Metrics Scraper (SMS): automated retrieval of citation and author data. Front Res Metr Anal. 2024 Feb 22;9:1335454. doi: 10.3389/frma.2024.1335454. eCollection 2024.
PubMed 38456123Ricci FS, D'Alessandro R, Soma A, Salvalaggio A, Rossi F, Rampone S, Gamberini G, Davico C, Peretta P, Cacciacarne M, Gaglini P, Pacca P, Pilloni G, Ragazzi P, Bertin D, Vallero SG, Fagioli F, Vitiello B. Development and application of a diagnostic and severity scale to grade post-operative pediatric cerebellar mutism syndrome. Eur J Pediatr. 2022 Mar;181(3):941-950. doi: 10.1007/s00431-021-04290-x. Epub 2021 Oct 14.
PubMed 34651204Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in refractory continuous spikes and waves during slow sleep: a controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5. doi: 10.1016/j.eplepsyres.2011.07.016. Epub 2011 Aug 31.
PubMed 21885255Strzelczyk A, Griebel C, Lux W, Rosenow F, Reese JP. The Burden of Severely Drug-Refractory Epilepsy: A Comparative Longitudinal Evaluation of Mortality, Morbidity, Resource Use, and Cost Using German Health Insurance Data. Front Neurol. 2017 Dec 22;8:712. doi: 10.3389/fneur.2017.00712. eCollection 2017.
PubMed 29312132Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644.
PubMed 24791078Estrin S, Hu Y, Shapiro D, Zhang P. Agglomeration costs limit sustainable innovation in cities in developing economies. PLoS One. 2024 Nov 14;19(11):e0308742. doi: 10.1371/journal.pone.0308742. eCollection 2024.
PubMed 39541289Sandesara UN. The narrative governance of life: Morality, melodrama, and the limits of biopower in western Indian efforts against sex selection. Med Anthropol Q. 2025 Jun;39(2):e12901. doi: 10.1111/maq.12901. Epub 2024 Nov 29.
PubMed 39612345van der Groen O, Latella C, Nosaka K, Edwards D, Teo WP, Taylor JL. Corticospinal and intracortical responses from both motor cortices following unilateral concentric versus eccentric contractions. Eur J Neurosci. 2023 Feb;57(4):619-632. doi: 10.1111/ejn.15897. Epub 2023 Jan 17.
PubMed 36512398
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children
- ClinicalTrials.gov ID
- NCT05825274
- Acronym / sponsor ID
- RefEpTDCs
- Keywords
- Drug-resistant epilepsy, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Spanish Foundation for Neurometrics DevelopmentUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 24 Apr 2023 (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.
Epilepsy is the fourth overall neurologic disorder, regardless of age and gender, affecting more than 50 million people worldwide. Modern epidemiological studies indicate that the global annualized cumulative incidence ranges between 42.8 and 67.8 new cases per 100,000 people each year, with figures scaling up to 139 per 100,000 in low- and middle-income regions. A community-based study conducted in France concluded that up to 22.5% of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial dysfunction, and a reduced quality of life.
Detailed description
The International League Against Epilepsy (ILAE) defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients is the drive to develop different approaches in order to offer alternatives for control.In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarization shifts, an enhanced probability of high-frequency and hypersynchronous activity of small neuronal networks, and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal connections.Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repeatedly, it generates long-lasting cortical excitability shifts through mechanisms resembling long-term depression (LTD). In this study, cathodal tDCS (c-tDCS) is utilized to apply a hyperpolarizing current directly over the primary epileptogenic focus, aiming to suppress pathological network activity and reduce seizure frequency in pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental: Active c-tDCS Group | Experimental | Device: Active Cathodal tDCSA cohort of 50 pediatric patients with drug-resistant focal epilepsy experiencing at least 3 seizures per week. Participants receive active cathodal transcranial direct current stimulation (c-tDCS) targeted over the primary epileptogenic focus. Digital electroencephalography (EEG) utilizing a 19-channel montage is performed immediately before and after the intervention period. Treatment efficacy on psychosocial outcomes is evaluated using the Quality of Life in Epilepsy Inventory for Adolescents/Children (QOLIE-31) questionnaire. |
| Device: Active Cathodal tDCS | Experimental | Device: Active Cathodal tDCSActive cathodal stimulation delivered at twice-weekly intervals. Each therapeutic session lasts 35 minutes, with the cathode electrode localized over the patient-specific epileptic focus to reduce cortical hyperexcitability. |
| : Placebo Comparator: Sham tDCS Group | Sham comparator | Device: Active Cathodal tDCSA control cohort of 50 pediatric patients with drug-resistant focal epilepsy experiencing at least 3 seizures per week. Participants undergo the identical procedural, preparation, and 19-channel EEG monitoring protocols before and after the intervention as the experimental group, but receive inactive sham (placebo) stimulation. Quality of life tracking is assessed via the QOLIE-31 questionnaire. |
Who may qualify
- Ages
- 18 to 120 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged between 4 and 6 years at the time of screening.
- Formally diagnosed with drug-resistant focal epilepsy according to the International League Against Epilepsy (ILAE) criteria (failure of adequate trials of two or more tolerated, appropriately chosen, and appropriately used antiepileptic drug regimens).
- Experiencing a baseline frequency of at least 3 clinical seizures per week, documented via a reliable prospective seizure diary kept by parents or caregivers.
- Patients whose legal guardians are willing and able to provide written informed consent, and patients who can provide assent when age-appropriate.
Key exclusion criteria (6 listed)
- Presence of metallic implants in the brain or skull (e.g., surgical clips, cochlear implants) near the site of electrode placement.
- History of severe cardiac arrhythmias, unstable cardiovascular disease, or baseline pacemaker dependent, which may compromise safety during Heart Rate Variability (HRV) monitoring.
- Progressive neurological disorders, neurodegenerative diseases, or active brain tumors.
- Recent changes in antiepileptic drug (AED) dosages or types within the 4 weeks prior to baseline screening.
- Any active skin lesions, inflammation, or structural cranial abnormalities at the target electrode site that prevent safe application of the tDCS pads.
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 |
|---|---|---|
| Active Cathodal tDCSAlso: Brain Noninvasive Electrical Stimulation, tDCS, PlaceboActive cathodal stimulation delivered at twice-weekly intervals. Each therapeutic session lasts 30 minutes, with the cathode electrode localized over the patient-specific epileptic focus to reduce cortical hyperexcitability. | Device | : Placebo Comparator: Sham tDCS Group, Device: Active Cathodal tDCS, Experimental: Active c-tDCS Group |
Primary outcome
Weekly Seizure Frequency
Time frame: Baseline and Week 24
Assessment of patient-reported quality of life. The total score ranges from 0 to 100 points, where higher scores indicate a better quality of life. This scale will be evaluated as a single independent outcome measure. BaselineF LIFE IN EPILEPSY - QOLIE-31.
Heart Rate Variability (HRV) Changes
Time frame: Baseline and Week 24
To evaluate cardiac safety, specific parameters will be extracted and analyzed from standard 12-lead ECG recordings. The assessed components will explicitly include: Heart Rate (bpm), PR interval (ms), QRS complex duration (ms), QT interval (ms), and corrected QT interval (QTc, ms) using Fridericia's formula
Change from Baseline in Seizure Frequency
Time frame: Baseline and Week 24
Evaluation of efficacy based on the change in seizure frequency. This metric will assess the number of observable seizures per 28-day period (seizures/28 days), as documented by patient/caregiver diaries, comparing the baseline phase to the final 4 weeks of the treatment period (up to Week 24).
Change from Baseline in Vital Signs
Time frame: Baseline and Week 24
Evaluation of clinical safety through the assessment of vital signs. The specific metrics to be evaluated independently as continuous variables include: Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Heart Rate (beats per minute), and Body Temperature (°C).
1 secondary outcome
Change in Brain Electrical Activity via Electroencephalogram (EEG)
Time frame: Baseline and Week 24
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 22 Sep 2026.
- Background: PubMed 38456123Cao Y, Cheung NA, Giustini D, LeDue J, Murphy TH. Scholar Metrics Scraper (SMS): automated retrieval of citation and author data. Front Res Metr Anal. 2024 Feb 22;9:1335454. doi: 10.3389/frma.2024.1335454. eCollection 2024.
- Background: PubMed 34651204Ricci FS, D'Alessandro R, Soma A, Salvalaggio A, Rossi F, Rampone S, Gamberini G, Davico C, Peretta P, Cacciacarne M, Gaglini P, Pacca P, Pilloni G, Ragazzi P, Bertin D, Vallero SG, Fagioli F, Vitiello B. Development and application of a diagnostic and severity scale to grade post-operative pediatric cerebellar mutism syndrome. Eur J Pediatr. 2022 Mar;181(3):941-950. doi: 10.1007/s00431-021-04290-x. Epub 2021 Oct 14.
- Results publication: PubMed 21885255Varga ET, Terney D, Atkins MD, Nikanorova M, Jeppesen DS, Uldall P, Hjalgrim H, Beniczky S. Transcranial direct current stimulation in refractory continuous spikes and waves during slow sleep: a controlled study. Epilepsy Res. 2011 Nov;97(1-2):142-5. doi: 10.1016/j.eplepsyres.2011.07.016. Epub 2011 Aug 31.
- Results publication: PubMed 29312132Strzelczyk A, Griebel C, Lux W, Rosenow F, Reese JP. The Burden of Severely Drug-Refractory Epilepsy: A Comparative Longitudinal Evaluation of Mortality, Morbidity, Resource Use, and Cost Using German Health Insurance Data. Front Neurol. 2017 Dec 22;8:712. doi: 10.3389/fneur.2017.00712. eCollection 2017.
- Results publication: PubMed 24791078Engel J Jr. Approaches to refractory epilepsy. Ann Indian Acad Neurol. 2014 Mar;17(Suppl 1):S12-7. doi: 10.4103/0972-2327.128644.
- Results publication: PubMed 39541289Estrin S, Hu Y, Shapiro D, Zhang P. Agglomeration costs limit sustainable innovation in cities in developing economies. PLoS One. 2024 Nov 14;19(11):e0308742. doi: 10.1371/journal.pone.0308742. eCollection 2024.
- Results publication: PubMed 39612345Sandesara UN. The narrative governance of life: Morality, melodrama, and the limits of biopower in western Indian efforts against sex selection. Med Anthropol Q. 2025 Jun;39(2):e12901. doi: 10.1111/maq.12901. Epub 2024 Nov 29.
- Results publication: PubMed 36512398van der Groen O, Latella C, Nosaka K, Edwards D, Teo WP, Taylor JL. Corticospinal and intracortical responses from both motor cortices following unilateral concentric versus eccentric contractions. Eur J Neurosci. 2023 Feb;57(4):619-632. doi: 10.1111/ejn.15897. Epub 2023 Jan 17.
- Individual participant dataSharing planned: Yes. biogdata4brain.com is the database where our foundation recorda all the clinical data of our assays
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.
Fernando Vargas Torgal, MD study chair
FSI, Fundacion Salud Infantil Elxe (Alcante)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cathodal tDCS in people with Other Forms of Epilepsy, Treatment Resistant, run by Spanish Foundation for Neurometrics Development at 1 site in United Kingdom.
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 22 Sep 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Weekly Seizure Frequency (time frame: Baseline and Week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825274, which also lists 8 linked publications.
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 22 Sep 2026.