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

NCT04158531 | Unknown DMC

• 3 other identifiers: NL66795.041.18NEF17-07METC19-336
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epileptic Seizure; Epilepsy Intractable; Motor Seizure

Keywords

cortical electrical stimulation; seizure detection; network stimulation

Outcome Measures

Primary Outcomes (2)

• seizure frequency - diary recorded in an app (MedApp)

  the number of seizures per day

  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.

  study start until 1 year after implantation of last patient

Secondary Outcomes (8)

• Motoric functioning - muscle strength as part of neurological examination

  study start until 1 year after implantation of last patient

• Motoric functioning - coordination as part of neurological examination

  study start until 1 year after implantation of last patient

• Motoric functioning - sensibility as part of neurological examination

  study start until 1 year after implantation of last patient

• Motoric functioning - reflexes as part of neurological examination

  study start until 1 year after implantation of last patient

• Simple functional abilities - nine hole peg test

  study start until 1 year after implantation of last patient

Study Arms (1)

REC2Stim

EXPERIMENTAL

Use electrocorticography (ECoG)-based seizure detection and cortical network stimulation upon seizure onset detection.

Device: ECoG sensing and stimulation

Interventions

ECoG sensing and stimulation DEVICE

Implant electrodes and a sensing+stimulation device, and use this for suppression of seizure activity

Also known as: Activa PC+S

REC2Stim

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Seizures; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy; Brain Diseases; Central Nervous System Diseases

Study Officials

• Frans Leijten, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frans Leijten, MD, PhD

CONTACT

+31 88 75 579 83; F.S.S.leijten@umcutrecht.nl

Nick Ramsey, PhD

CONTACT

+31 88 755 6862; N.F.Ramsey@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: study coordinator

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 8, 2019
• Study Start: November 4, 2019
• Primary Completion: March 31, 2022
• Study Completion: July 31, 2022
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: From January 2023, no end date

Locations

NL (1)