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

2019-11-14 17:39:44 | BioPortfolio

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.

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.

Study Design

Conditions

Epileptic Seizure

Intervention

ECoG sensing and stimulation

Location

University Medical Center Utrecht
Utrecht
Netherlands
3584 CX

Status

Recruiting

Source

UMC Utrecht

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-11-14T17:39:44-0500

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Medical and Biotech [MESH] Definitions

Epileptic condition in which adequate trials of two tolerated and appropriately chosen and used ANTIEPILEPTIC DRUGS schedules to achieve sustained seizure freedom failed.

Recurrent conditions characterized by epileptic seizures which arise diffusely and simultaneously from both hemispheres of the brain. Classification is generally based upon motor manifestations of the seizure (e.g., convulsive, nonconvulsive, akinetic, atonic, etc.) or etiology (e.g., idiopathic, cryptogenic, and symptomatic). (From Mayo Clin Proc, 1996 Apr;71(4):405-14)

EPILEPTIC SEIZURES that are of similar type and age of onset and have other similar features (e.g., clinical course, EEG findings, genetic association and neuropathology).

The ability or act of sensing and transducing ACOUSTIC STIMULATION to the CENTRAL NERVOUS SYSTEM. It is also called audition.

Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317)

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