Epilepsy Intractable Clinical Trial
— REC2StimOfficial 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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | July 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Center Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seizure frequency - diary recorded in an app (MedApp) | the number of seizures per day | study start until 1 year after implantation of last patient | |
Primary | 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 | 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). | study start until 1 year after implantation of last patient | |
Secondary | 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. | study start until 1 year after implantation of last patient | |
Secondary | 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. | study start until 1 year after implantation of last patient | |
Secondary | 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. | study start until 1 year after implantation of last patient | |
Secondary | 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. | study start until 1 year after implantation of last patient | |
Secondary | 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). | study start until 1 year after implantation of last patient | |
Secondary | 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). | study start until 1 year after implantation of last patient | |
Secondary | 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) | study start until 1 year after implantation of last patient |
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