Epilepsy, RefractoryNeuroSeizureNCT05254730
Using Micro-filaments to Detect "fast Ripples" and Improve the Identification of the Epileptogenic Zone
A study testing macro-micro tetrodes for intracranial recording in people with Epilepsy, Refractory, run by Adrien Peyrache at 1 site in Canada.
Trial summary
record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Refractory
- What is being tested?
- macro-micro tetrodes for intracranial recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 30 Dec 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- inclusion criteria is determined based on the clinical diagnosis of the refractory epilepsy and the admissibility of the patient for the stereoelectroencephalography (sEEG) procedure
Who cannot join
- severe psychiatric disorders,
- severe agitation during their crisis
- contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
- contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
- anti thrombotic ongoing treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University
Montreal, Quebec, H3A 2B4
Adrien Peyrache, PhD, 514-398-6780, adrien.peyrache@mcgill.ca
Birgit Frauscher, PhD, MD, 514-398-1911, birgit.frauscher@mcgill.ca
About this study
record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy
Read the detailed description
This study would improve the localization of the epileptogenic zone and reduce the overall duration of monitoring, especially in patients who do not experience a sufficient number of seizures during the implantation period. In addition, it would be possible to use micro-electrodes and propose a better surgical treatment to some patients whose preliminary assessment with macro-electrodes has not provided significant results. Finally, the data collected during this study will help us to further understand pathological brain activity and to describe the neuronal circuitry that gives rise to cortical signals and the relationships between them (from spindles to high frequency oscillations).
- Conditions
- Epilepsy, Refractory
- Being tested
- macro-micro tetrodes for intracranial recording
- 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.
macro-micro tetrodes for intracranial recordingDevice
novel design of tetrode micro electrodes within the standard macro intracranial electrodes used clinically for identification of the epileptogenic zone
| Study group | Role | What they receive |
|---|---|---|
| micro-macroelectrodes | Experimental | Patients will be implanted with usually the novel intracerebral micro-macroelectrodes (instead of the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. Receives: Device: macro-micro tetrodes for intracranial recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes
sum of number of single units recorded and the number of fast ripples (FRs)
Measured: 1 week after implant
Secondary outcomes (1)
Efficiency of microelectrodes compared to macroelectrodes
proportion and quality of the FRs recorded by the macro-blocks immediately adjacent to the microelectrodes located in the EZ
Measured: 10 days after implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Sep 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, RefractoryStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adrien Peyrache
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adrien Peyrache, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254730
- Sponsor's protocol ID
- 2019-5000
- Acronym
- NeuroSeizure
- Status last verified
- Nov 2024
- First submitted
- 15 Feb 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Micro-filaments to Detect "fast Ripples" and Improve the Identification of the Epileptogenic Zone
- ClinicalTrials.gov ID
- NCT05254730
- Acronym / sponsor ID
- NeuroSeizure / 2019-5000
- Conditions
- Epilepsy, Refractory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Adrien PeyracheUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 24 Feb 2022 (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.
record fast ripples with novel intracranial electrodes with micro-tetrodes to improve the identification of epileptogenic zone (EZ) and investigate the neuronal circuits underlying brain dynamics associated with epilepsy
Detailed description
This study would improve the localization of the epileptogenic zone and reduce the overall duration of monitoring, especially in patients who do not experience a sufficient number of seizures during the implantation period. In addition, it would be possible to use micro-electrodes and propose a better surgical treatment to some patients whose preliminary assessment with macro-electrodes has not provided significant results. Finally, the data collected during this study will help us to further understand pathological brain activity and to describe the neuronal circuitry that gives rise to cortical signals and the relationships between them (from spindles to high frequency oscillations).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro-macroelectrodes | Experimental | Device: macro-micro tetrodes for intracranial recordingPatients will be implanted with usually the novel intracerebral micro-macroelectrodes (instead of the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- inclusion criteria is determined based on the clinical diagnosis of the refractory epilepsy and the admissibility of the patient for the stereoelectroencephalography (sEEG) procedure
Key exclusion criteria (5 listed)
- severe psychiatric disorders,
- severe agitation during their crisis
- contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
- contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
- anti thrombotic ongoing treatment.
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 |
|---|---|---|
| macro-micro tetrodes for intracranial recordingnovel design of tetrode micro electrodes within the standard macro intracranial electrodes used clinically for identification of the epileptogenic zone | Device | micro-macroelectrodes |
Primary outcome
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes
Time frame: 1 week after implant
sum of number of single units recorded and the number of fast ripples (FRs)
1 secondary outcome
Efficiency of microelectrodes compared to macroelectrodes
Time frame: 10 days after implant
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 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing macro-micro tetrodes for intracranial recording in people with Epilepsy, Refractory, run by Adrien Peyrache at 1 site in Canada.
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 1 inclusion and 5 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 20 Nov 2024. 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 Canada. 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?
Contact Adrien Peyrache, PhD (514-398-6780, adrien.peyrache@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the recording of fast ripples (FRs) and single neuron activity in the brain with the micro tetrodes (time frame: 1 week after implant). 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 20 Nov 2024.