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New treatment option for Epilepsy, Drug Resistant
Official title Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
ClinicalTrials.gov ID: NCT06248333
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 65
You may be able to join if
- 14-65 years of age, inclusive, at Screening Visit.
- Refractory to anti-seizure medications (ASMs).
- Diagnosed with focal motor epilepsy, which meets the following items:
- Seizure mainly presents as focal tonic, myoclonic, or primary motor seizure (including primary sensory seizure), with or without secondary bilateral...
- After a comprehensive evaluation, the epileptogenic zone was presumed to predominantly involve the unilateral or bilateral central area (precentral...
You likely can't join if
- 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;
- Structural lesion of the subthalamic nucleus;
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive...
See the full eligibility criteria
- 14-65 years of age, inclusive, at Screening Visit.
- Refractory to anti-seizure medications (ASMs).
- Diagnosed with focal motor epilepsy, which meets the following items:
- 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...
- Within 1 month prior to the Screening Visit (M-3), the following conditions are met:
- At least 3 focal onset seizures (with or without secondary bilateral tonic-clonic seizure).
- Subject is receiving at least one type of ASM(s), and the regimen has been stable (no addition or removal of ASM(s) [not counting brief rescue medicines such as benzodiazepines]; dose adjustments are permitted to...
- Within the baseline period (3 months after the Screening Visit [M-3]), the following conditions are met:
- The patient or their caregiver is capable of completing the seizure diary.
- Seizure diary shows an average of 3 or more partial-onset seizures (with or without secondary bilateral tonic-clonic seizure) per month during the Baseline Period, with no more than 30 days between seizures.
- The regimen of ASM(s) has been stable (no addition or removal of ASM(s) [not counting brief rescue medicines such as benzodiazepines]; dose adjustments are permitted to ASM(s)).
- After comprehensive preoperative evaluation, patients who are considered unsuitable for or refuse resection surgery, or those for whom the effects of epileptic focus resection and thermocoagulation surgery are not...
- Informed consent signed.
- 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;
- Structural lesion of the subthalamic nucleus;
- 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...
- Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- IQ \< 55 or severe cognitive dysfunction, unable to complete the study;
- Diagnosed with a progressive neurological disorder (including progressive Rasmussen'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 or self-injurious tendencies), schizophrenia, or...
- Diagnosed with other serious physical disorders, internal diseases or severe abnormalities 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.