Brain zaps for seizures: tiny trial tests new target
NCT ID NCT06436547
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether deep brain stimulation (DBS) of a brain region called the subiculum can safely reduce seizures in 6 people with drug-resistant temporal lobe epilepsy and bilateral hippocampal sclerosis. Participants receive a DBS device, and researchers track seizure frequency and quality of life over time. The goal is to see if this approach works for those who cannot have standard surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- deep brain stimulation (DBS) device targeting the subiculum
- What this could lead to
- If it works, this could offer a new treatment option for people with drug-resistant epilepsy who cannot have surgery.
- What could go wrong
- This is a very small pilot trial with only 6 participants, so results may not apply widely. The procedure carries surgical risks, and the long-term benefits are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 once or more in recent 1 month. * 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 satisfactory. * Participants must have had a non-invasive video-EEG monitoring revealing seizure semiology and ictal EEG consistent with bilateral Temporal Lobe Epilepsy * Biliteral hippocampal atrophy on MRI T1 imaging with increased ipsilateral mesial signal on T2 imaging * Informed consent signed. 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 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; * 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 neurodegenerative disorders; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xuanwu Hospital,Capital Medical University
Beijing, Beijing Municipality, 100053, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.