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REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex. (REC2Stim)

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ClinicalTrials.gov Identifier: NCT04158531
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dorien van Blooijs, UMC Utrecht

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Epileptic Seizure Epilepsy Intractable Motor Seizure Device: ECoG sensing and stimulation Not Applicable

Detailed Description:

The investigators will include five 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Rational Extra-eloquent Closed-loop Cortical Stimulation (REC2Stim) as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.
Estimated Study Start Date : November 4, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
Experimental: REC2Stim
Use electrocorticography (ECoG)-based seizure detection and cortical network stimulation upon seizure onset detection.
Device: ECoG sensing and stimulation
Implant electrodes and a sensing+stimulation device, and use this for suppression of seizure activity
Other Name: Activa PC+S




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Motoric functioning - muscle strength as part of neurological examination [ Time Frame: study start until 1 year after implantation of last patient ]
    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).

  2. Motoric functioning - coordination as part of neurological examination [ Time Frame: study start until 1 year after implantation of last patient ]
    The investigators perform neurological examination during each outpatient clinic visit. Coordination is rated as normal or abnormal.

  3. Motoric functioning - sensibility as part of neurological examination [ Time Frame: study start until 1 year after implantation of last patient ]
    The investigators perform neurological examination during each outpatient clinic visit. Sensibility is rated as normal or abnormal.

  4. Motoric functioning - reflexes as part of neurological examination [ Time Frame: study start until 1 year after implantation of last patient ]
    The investigators perform neurological examination during each outpatient clinic visit. Reflexes are rated as normal or abnormal.

  5. Simple functional abilities - nine hole peg test [ Time Frame: study start until 1 year after implantation of last patient ]
    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.

  6. Complex functional abilities - Action Research Arm Test (ARAT) [ Time Frame: study start until 1 year after implantation of last patient ]
    The investigators use the ARAT before implantation and 1 year after implantation. Scale ranges from 0-57 points (bad - normal performance).

  7. Quality of life questionnaire [ Time Frame: study start until 1 year after implantation of last patient ]
    The patient fills in the Assessment of Quality of Life (AQoL-8D). Scale ranges from 35-175 (high - low quality of life).

  8. Participation abilities - Utrecht´s Scale for Evaluation of Rehabilitation (USER)- Participation questionnaire [ Time Frame: study start until 1 year after implantation of last patient ]
    The patient fills in the USER-participation questionnaire. Score ranges from 0-500 (low - good participation)



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158531


Contacts
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Contact: Frans Leijten, MD, PhD +31 88 75 579 83 F.S.S.leijten@umcutrecht.nl
Contact: Nick Ramsey, PhD +31 88 755 6862 N.F.Ramsey@umcutrecht.nl

Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Frans Leijten, MD, PhD    +31 88 75 579 83    F.S.S.leijten@umcutrecht.nl   
Contact: Nick Ramsey, PhD    +31 88 755 6862    N.F.Ramsey@umcutrecht.nl   
Principal Investigator: Frans Leijten, MD, PhD         
Sub-Investigator: Nick Ramsey, PhD         
Sub-Investigator: Erik Aarnoutse, PhD         
Sub-Investigator: Geertjan Huiskamp, PhD         
Sub-Investigator: Dorien van Blooijs, MSc         
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Frans Leijten, MD, PhD UMC Utrecht

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Responsible Party: Dorien van Blooijs, study coordinator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT04158531     History of Changes
Other Study ID Numbers: NL66795.041.18
NEF17-07 ( Other Grant/Funding Number: Dutch Epilepsy Foundation )
METC19-336 ( Registry Identifier: MREC Utrecht )
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: selected datasets will be available through a public repository after publication of results
Time Frame: From January 2023, no end date

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dorien van Blooijs, UMC Utrecht:
cortical electrical stimulation
seizure detection
network stimulation
Additional relevant MeSH terms:
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Epilepsy
Seizures
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms