Epileptic SeizureREC2StimNCT04158531
REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
A study testing ECoG sensing and stimulation in people with Epileptic Seizure and Epilepsy Intractable, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
People with central lobe epilepsy (CLE), with seizures arising from the primary sensorimotor cortex, typically show a high rate of convulsive seizures that do not respond to anti-epileptic drugs, but have a large impact on quality of life. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Epileptic Seizure, Epilepsy Intractable, Motor Seizure
- What is being tested?
- ECoG sensing and stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Nov 2019to 31 Jul 2022
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- potential central lobe epilepsy
- on average 2 or more seizures per day or ongoing Epilepsia Partialis Continua (EPC)
- mentally and physically capable of giving informed consent
- minimally 3 anti-epileptic drugs been admitted without effect on seizure frequency (refractory epilepsy)
Who cannot join
- coagulopathy, including use of anticoagulant or antiplatelet agents
- known allergy to the materials of the implant
- progressive neurological or systemic disease
- contra-indications to the presence of a chronically implanted device, such as the need for repeated MRI, or concurrent infections
- any brain lesion that would place the patient at an elevated risk for bleeding
- any progressive brain disease, e.g. Rasmussen's encephalitis or glioma
Show all 9Show fewer
- presence of any active implanted metallic device, such as cardiac pace-maker, vagal nerve or deep brain stimulator, cochlear implants, spinal cord stimulator or metallic parts from non-medical origin
- presence of aneurysm clips
- seizure onset zone (SOZ) outside eloquent cortex
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, 3584 CX
Frans Leijten, MD, PhD, +31 88 75 579 83, F.S.S.leijten@umcutrecht.nl
Nick Ramsey, PhD, +31 88 755 6862, N.F.Ramsey@umcutrecht.nl
About this study
Official title: Rational Extra-eloquent Closed-loop Cortical Stimulation (REC2Stim) as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
People with central lobe epilepsy (CLE), with seizures arising from the primary sensorimotor cortex, typically show a high rate of convulsive seizures that do not respond to anti-epileptic drugs, but have a large impact on quality of life. They often seek surgical relief, but since the area contains the body's indispensable sensorimotor representation, CLE surgery will lead to permanent functional deficits. Cortical stimulation case studies in CLE have shown seizure frequency reduction of more than 90%, but in our experience, stimuli in the central lobe can hardly be applied without interfering with motor function.
The investigators propose cortical electrical stimulation therapy of a conceptually novel type. The investigators systematically determine individual stimulation settings, stimulation site and a seizure detection algorithm. In REC2Stim (Rational Extra-eloquent Closed-loop Cortical Stimulation), at the start of a seizure, a train of electric pulses is delivered to a nearby extra-eloquent area connected with the epileptogenic area within the sensorimotor cortex. Success will constitute a therapeutic modality for pharmaco-resistant patients with an epileptic focus in eloquent areas.
Read the detailed description
The investigators will include ten patients with CLE, aged 16 years and older, in whom pre-surgical chronic intracranial EEG monitoring has revealed a seizure onset in the primary sensorimotor cortex. Patients should have on average at least two seizures per day.
Clinical intracranial EEG monitoring (normally 7-10 days) will be extended with two extra monitoring days, for systematic testing of different stimulation settings and their effect on interictal epileptiform EEG activity (as a surrogate marker for ictal epileptiform activity), from which site and parameters for chronic stimulation will be determined.
Upon removal of the clinically implanted electrodes, a neurostimulator with sensing capabilities, Activa PC+S, will be implanted and attached to two subdural leads with electrodes covering the predefined stimulation site and the eloquent epileptogenic area.
During a data collection phase, stimulation-free data will then be collected to train the seizure detection algorithm up to at least 50% sensitivity.
Finally, the REC2Stim phase will be started, in which cortical stimulation is applied when seizure activity is detected. Study participation is one year. When REC2Stim turns out effective in month 10 and 11 after implantation of the neurostimulator, 2 weeks of sham stimulation will follow in month 12.
- Conditions
- Epileptic Seizure, Epilepsy Intractable, Motor Seizure
- Being tested
- ECoG sensing and stimulation
- Keywords
- cortical electrical stimulation, seizure detection, network stimulation
- Medical subject headings
- Seizures, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG sensing and stimulationDevice
Also called Activa PC+S
Implant electrodes and a sensing+stimulation device, and use this for suppression of seizure activity
| Study group | Role | What they receive |
|---|---|---|
| REC2Stim | Experimental | Use electrocorticography (ECoG)-based seizure detection and cortical network stimulation upon seizure onset detection. Receives: Device: ECoG sensing and stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure frequency - diary recorded in an app (MedApp)
the number of seizures per day
Measured: study start until 1 year after implantation of last patient
seizure severity - diary recorded in an app (MedApp)
the severity of the seizures, experienced by the patient. A scale of intensity from 0-10 (low - high severity) can be selected. Also the seizure type can be selected.
Measured: study start until 1 year after implantation of last patient
Secondary outcomes (8)
Motoric functioning - muscle strength as part of neurological examination
The investigators perform neurological examination during each outpatient clinic visit. We test muscle strength and scale that with the Medical Research Council Scale (MRC) (0-5: no contraction - normal strength).
Measured: study start until 1 year after implantation of last patient
Motoric functioning - coordination as part of neurological examination
The investigators perform neurological examination during each outpatient clinic visit. Coordination is rated as normal or abnormal.
Measured: study start until 1 year after implantation of last patient
Motoric functioning - sensibility as part of neurological examination
The investigators perform neurological examination during each outpatient clinic visit. Sensibility is rated as normal or abnormal.
Measured: study start until 1 year after implantation of last patient
Motoric functioning - reflexes as part of neurological examination
The investigators perform neurological examination during each outpatient clinic visit. Reflexes are rated as normal or abnormal.
Measured: study start until 1 year after implantation of last patient
Simple functional abilities - nine hole peg test
The investigators use the nine-hole peg test before implantation and 1 year after implantation. The investigators record the time it takes to place 9 sticks in openings and back on the plate again.
Measured: study start until 1 year after implantation of last patient
Complex functional abilities - Action Research Arm Test (ARAT)
The investigators use the ARAT before implantation and 1 year after implantation. Scale ranges from 0-57 points (bad - normal performance).
Measured: study start until 1 year after implantation of last patient
Quality of life questionnaire
The patient fills in the Assessment of Quality of Life (AQoL-8D). Scale ranges from 35-175 (high - low quality of life).
Measured: study start until 1 year after implantation of last patient
Participation abilities - Utrecht´s Scale for Evaluation of Rehabilitation (USER)- Participation questionnaire
The patient fills in the USER-participation questionnaire. Score ranges from 0-500 (low - good participation)
Measured: study start until 1 year after implantation of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start4 Nov 2019
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epileptic SeizureStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an early feasibility study in which the effect and safety of cortical network stimulation in patients with central lobe epilepsy is investigated.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dorien van Blooijs, UMC Utrecht
- Investigators
- Frans Leijten, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158531
- Sponsor's protocol ID
- NL66795.041.18
- Other IDs
- NEF17-07, METC19-336
- Acronym
- REC2Stim
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: selected datasets will be available through a public repository after publication of results
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rational Extra-eloquent Closed-loop Cortical Stimulation (REC2Stim) as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
- ClinicalTrials.gov ID
- NCT04158531
- Acronym / sponsor ID
- REC2Stim / NL66795.041.18
- Conditions
- Epileptic Seizure, Epilepsy Intractable, Motor Seizure
- Keywords
- cortical electrical stimulation, seizure detection, network stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 8 Nov 2019 (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.
People with central lobe epilepsy (CLE), with seizures arising from the primary sensorimotor cortex, typically show a high rate of convulsive seizures that do not respond to anti-epileptic drugs, but have a large impact on quality of life. They often seek surgical relief, but since the area contains the body's indispensable sensorimotor representation, CLE surgery will lead to permanent functional deficits. Cortical stimulation case studies in CLE have shown seizure frequency reduction of more than 90%, but in our experience, stimuli in the central lobe can hardly be applied without interfering with motor function.
The investigators propose cortical electrical stimulation therapy of a conceptually novel type. The investigators systematically determine individual stimulation settings, stimulation site and a seizure detection algorithm. In REC2Stim (Rational Extra-eloquent Closed-loop Cortical Stimulation), at the start of a seizure, a train of electric pulses is delivered to a nearby extra-eloquent area connected with the epileptogenic area within the sensorimotor cortex. Success will constitute a therapeutic modality for pharmaco-resistant patients with an epileptic focus in eloquent areas.
Detailed description
The investigators will include ten patients with CLE, aged 16 years and older, in whom pre-surgical chronic intracranial EEG monitoring has revealed a seizure onset in the primary sensorimotor cortex. Patients should have on average at least two seizures per day.
Clinical intracranial EEG monitoring (normally 7-10 days) will be extended with two extra monitoring days, for systematic testing of different stimulation settings and their effect on interictal epileptiform EEG activity (as a surrogate marker for ictal epileptiform activity), from which site and parameters for chronic stimulation will be determined.
Upon removal of the clinically implanted electrodes, a neurostimulator with sensing capabilities, Activa PC+S, will be implanted and attached to two subdural leads with electrodes covering the predefined stimulation site and the eloquent epileptogenic area.
During a data collection phase, stimulation-free data will then be collected to train the seizure detection algorithm up to at least 50% sensitivity.
Finally, the REC2Stim phase will be started, in which cortical stimulation is applied when seizure activity is detected. Study participation is one year. When REC2Stim turns out effective in month 10 and 11 after implantation of the neurostimulator, 2 weeks of sham stimulation will follow in month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an early feasibility study in which the effect and safety of cortical network stimulation in patients with central lobe epilepsy is investigated.
| Arm | Type | Receives |
|---|---|---|
| REC2Stim | Experimental | Device: ECoG sensing and stimulationUse electrocorticography (ECoG)-based seizure detection and cortical network stimulation upon seizure onset detection. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- potential central lobe epilepsy
- on average 2 or more seizures per day or ongoing Epilepsia Partialis Continua (EPC)
- mentally and physically capable of giving informed consent
- minimally 3 anti-epileptic drugs been admitted without effect on seizure frequency (refractory epilepsy)
Key exclusion criteria (9 listed)
- coagulopathy, including use of anticoagulant or antiplatelet agents
- known allergy to the materials of the implant
- progressive neurological or systemic disease
- contra-indications to the presence of a chronically implanted device, such as the need for repeated MRI, or concurrent infections
- any brain lesion that would place the patient at an elevated risk for bleeding
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 |
|---|---|---|
| ECoG sensing and stimulationAlso: Activa PC+SImplant electrodes and a sensing+stimulation device, and use this for suppression of seizure activity | Device | REC2Stim |
Primary outcome
seizure frequency - diary recorded in an app (MedApp)
Time frame: study start until 1 year after implantation of last patient
the number of seizures per day
seizure severity - diary recorded in an app (MedApp)
Time frame: study start until 1 year after implantation of last patient
the severity of the seizures, experienced by the patient. A scale of intensity from 0-10 (low - high severity) can be selected. Also the seizure type can be selected.
8 secondary outcomes
Motoric functioning - muscle strength as part of neurological examination
Time frame: study start until 1 year after implantation of last patient
Motoric functioning - coordination as part of neurological examination
Time frame: study start until 1 year after implantation of last patient
Motoric functioning - sensibility as part of neurological examination
Time frame: study start until 1 year after implantation of last patient
Motoric functioning - reflexes as part of neurological examination
Time frame: study start until 1 year after implantation of last patient
Simple functional abilities - nine hole peg test
Time frame: study start until 1 year after implantation of last patient
Complex functional abilities - Action Research Arm Test (ARAT)
Time frame: study start until 1 year after implantation of last patient
Quality of life questionnaire
Time frame: study start until 1 year after implantation of last patient
Participation abilities - Utrecht´s Scale for Evaluation of Rehabilitation (USER)- Participation questionnaire
Time frame: study start until 1 year after implantation of last patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Individual participant dataSharing planned: Yes. selected datasets will be available through a public repository after publication of results
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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.
Frans Leijten, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECoG sensing and stimulation in people with Epileptic Seizure and Epilepsy Intractable, run by UMC Utrecht at 1 site in Netherlands.
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 9 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: status not confirmed, as of the sponsor's last update on 20 Dec 2019. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frans Leijten, MD, PhD (+31 88 75 579 83, F.S.S.leijten@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure frequency - diary recorded in an app (MedApp) (time frame: study start until 1 year after implantation of last patient). The study lists 2 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 20 Dec 2019.