Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
ConditionEpilepsy, Drug Resistant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-65
SponsorXuanwu Hospital, Beijing
About this trial
The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of subthalamic nucleus (STN) as adjunctive therapy for reducing the frequency of seizures in drug-resistant focal motor epilepsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
14-65 years of age, inclusive, at Screening Visit.
Refractory to anti-seizure medications (ASMs).
Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral tonic-clonic seizure.
After a comprehensive evaluation, the epileptogenic zone was presumed to predominantly involve the unilateral or bilateral central area (precentral gyrus, postcentral gyrus, and paracentral lobule) or supplementary motor area according to comprehensive presurgical evaluation.
Disqualifiers
Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
Seizures mainly present as complex motor seizures (e.g., hyperkinetic, automatisms, etc.);
Tonic-clonic status epilepticus within12 months;
Psychogenic non-epileptic seizures within 12 months;
Trial design
Design model
Parallel
Treatments tested in this trial
STN-DBS ON
DeviceStimulation ON
STN-DBS OFF
DeviceStimulation OFF
Treatment groups
33 Participants
are divided into 2 treatment groupsGroup A: Active StimulationExperimental treatment 1 intervention
Group B: Sham StimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Median Percent Change in Seizure Frequency
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
Through the end of the three-month blinded phaseSecondary outcomes
1
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Time frame
Through the end of the three-month blinded phase2
Seizure Severity
The percent change from baseline in seizure severity evaluated by Liverpool seizure severity scale (LSSS) across the double-blind period.
Time frame
Through the end of the three-month blinded phase3
Seizure-free Days
Change in percentage of seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.
Time frame
Through the end of the three-month blinded phase4
The maximum length of seizure-free Intervals
Percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.
Time frame
Through the end of the three-month blinded phaseSponsors and contacts
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Xuanwu Hospital, Beijing
Lead sponsor
Beijing Tiantan Hospital
Collaborator
Beijing Sanbo Brain Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
Peking University
Collaborator
Source ClinicalTrials.gov