Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
ConditionEpilepsy, Drug Resistant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing
About this trial
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants are between the ages of 14 -65 years of age
Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
Persistence of disabling seizures at least 3 times per month or greater,
Informed consent signed.
Disqualifiers
Structural alterations are present in the extreme capsule.
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 any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
Trial design
Design model
Single group
Treatments tested in this trial
EC-DBS ON
DeviceThe surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for drug-resistant epilepsy.The targets used in this study are extreme capsule.The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the epilepsy specialist.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: EC-DBS groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Seizure frequency (SF28)
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.
Time frame
Up to 1 year after EC-DBSSecondary outcomes
1
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Time frame
Up to 1 year after EC-DBS2
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score.
Time frame
Up to 1 year after EC-DBS3
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Time frame
Up to 1 year after EC-DBS4
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow
Time frame
Up to 1 year after EC-DBSSponsors and contacts
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Source ClinicalTrials.gov
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