Phase
Condition
Epilepsy
Seizure Disorders
Scar Tissue
Treatment
Subiculum-DBS ON
Clinical Study ID
Ages 14-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants are between the ages of 14 -65 years of age
Refractory to anti-seizure medications (ASMs).
Persistence of disabling seizures at least 3 times per 3 months or greater, and onceor more in recent 1 month.
After comprehensive preoperative evaluation, patients who are considered unsuitablefor or refuse resection surgery, or those for whom the effects of epileptic focusresection and thermocoagulation surgery are not satisfactory.
Participants must have had a non-invasive video-EEG monitoring revealing seizuresemiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy
Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesialsignal on T2 imaging
Informed consent signed.
Exclusion
Exclusion Criteria:
Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
Psychogenic non-epileptic seizures within 12 months;
Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or anymetallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagalnerve stimulators are allowed if the parameter remains stable for at least 3 monthsprior to the screening visit;
Risk factors that would put the participant at risk for intraoperative orpostoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need forchronic anticoagulation or antiplatelet aggregation medications;
IQ < 55 or severe cognitive dysfunction, unable to complete the study;
Diagnosed with a progressive neurological disorder (including progressiveRasmussen's encephalitis, etc.);
Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal orself-injurious tendencies), schizophrenia, or neurodegenerative disorders;
Diagnosed with other serious physical disorders, internal diseases or severeabnormalities in liver or kidney function;
Pregnant, or planning to pregnant within 2 years;
Participation in another clinical study within 3 months;
Not suitable for enrollment as assessed by the multidisciplinary team of the center.
Study Design
Study Description
Connect with a study center
Xuanwu Hospital,Capital Medical University
Beijing, Beijing 100053
ChinaSite Not Available
Xuanwu Hospital,Capital Medical University
Beijing 1816670, Beijing Municipality 2038349 100053
ChinaSite Not Available

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