Smart brain pacemaker aims to stop seizures while you sleep
NCT ID NCT07568860
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study will test a new way to use deep brain stimulation (DBS) in 4 adults with Lennox-Gastaut syndrome, a severe form of epilepsy. The device will automatically adjust stimulation based on whether the person is awake or asleep. Researchers want to see if this personalized approach reduces motor seizures better than standard DBS and if it is safe.
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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 4 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2031
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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18 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: * 18-65 years of age * Diagnosis of Lennox-Gastaut Syndrome (LGS) with confirmed generalized seizures, including generalized tonic or tonic-clonic (GTC) seizures. Participants may also have complex partial, atypical absences or atonic seizures, but these will not count toward minimum seizure frequency eligibility. * Diagnosis is based on prior video EEG confirmation performed in the last 3 years. Scalp EEG showing slow spike-wave discharges and paroxysmal fast activity. * At least four seizures per month (GTC or tonic) on average during the three months preceding enrollment. * Medically intractable epilepsy, defined as failure to achieve acceptable seizure control despite trials of at least two antiseizure medications (ASMs). * Nonlocalized seizures, as determined by standard diagnostic studies. * Stable doses of two or more ASMs for at least one month prior to enrollment (rescue benzodiazepines for acute seizure clusters permitted). * Participants with vagus nerve stimulation (VNS) must have stable settings for at least two months prior to enrollment and throughout the study. * Subjective reporting of sleep disturbances. * Participant or legal guardian can provide informed consent and maintain an online seizure log, alone or with assistance. * Participant is willing to remain on a stable ASM regimen (except use of variable dose of rescue medications permitted) throughout the study and able to attend scheduled clinic visits. * Reliable caregiver is available to assist with seizure diary maintenance. Exclusion Criteria: * Predominant seizure type is focal-onset seizures. * Anatomical brain abnormalities precluding DBS implantation, or discrete brain lesions on MRI (e.g., cortical malformation, tuber, or sclerosis). * Unable to obtain brain MRI due to metal that is not compatible with 3T MRI. * History of psychogenic non-epileptic seizures or unstable psychiatric disorders, including suicidal ideation or intent within the last six months. * Clinically significant medical conditions increasing risk for pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension). * Participant is pregnant or plans to become pregnant during the study. * Participation in another therapeutic investigational drug or device study. * Requirement for diathermy treatments during physical or occupational therapy. * In the opinion of the investigator or eligibility adjudication committee, the subject is unsuitable for the procedure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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