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.
This is a multicenter, randomized, double-blind, sham-controlled, parallel-group trial that aims to investigate the efficacy of STN-DBS in reducing the frequency of seizures in drug-resistant focal motor epilepsy. Participants who were eligible for the inclusion criteria and ineligible for the exclusion criteria will be randomly assigned into two groups by a 1:1 ratio. The primary purpose of this study is to compare active STN-DBS with sham STN-DBS in reducing seizure frequency. Both intent analysis (ITT) and compliance program set (PPS) were used for analysis. Only high-volume centers with a proven track record will be included. The STEM trial will be conducted in 5 sites in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
33
Stimulation ON
Stimulation OFF
Xuanwu Hospital, Beijing
Beijing, Beijing Municipality, China
RECRUITINGMedian 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 phase
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 phase
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 phase
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 phase
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 phase
Life quality evaluation
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Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Motor function evaluation
Percentage change from baseline in Unified Parkinson's Disease Rating Scale part II \& part III (UPDRS II-III) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Cognitive function evaluation (MMSE)
Percentage change from baseline in Mini-Mental State Examination (MMSE) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Cognitive function evaluation (MoCA)
Percentage change from baseline in Montreal Cognitive Assessment (MoCA) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Psychologic Evaluation (Anxiety)
Percentage change from baseline in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Psychologic Evaluation (Depression)
Percentage change from baseline in Hamilton Depression Rating Scale (HAMD) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Sleep Quality
Percentage change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 3 months after randomization.
Time frame: Through the end of the three-month blinded phase
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Time frame: Through Month 11 of the open-label follow-up phase
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-up.
Time frame: Through Month 11 of the open-label follow-up phase