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Brain pacemaker trial aims to cut seizures in kids with severe epilepsy

NCT ID NCT06924086

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether deep brain stimulation (DBS) can safely reduce seizures in children aged 5-14 with Lennox-Gastaut syndrome, a severe form of epilepsy. The trial uses a special device called Picostim to send electrical pulses to the brain. Researchers will track seizure frequency using caregiver diaries and EEG recordings. The goal is to improve seizure control, not to cure the condition.

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

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

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

5 to 14 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Children enrolled in this study must: * Be 5-14 years of age at consent. * Have a diagnosis of LGS, as determined by: * Slow (\<3.0Hz) spike-and-wave pattern and/or fast wave pattern (tonic seizures) detected on EEG at least six-months prior to the enrolment into the baseline period * History of drop seizures (tonic, atonic, or tonic-clonic) that precedes at least six-months prior to the enrolment into the baseline period * Have experienced at least 10 seizures in the four weeks prior to enrolment. * Have tried and not responded to two or more antiseizure medications prior to enrolment. * Be taking one or more anti-seizure medication(s) at a stable dose for at least the four weeks prior to enrolment. * Have a carer who is willing for their child's maintenance anti-seizure medications and ketogenic diet (if relevant) to be unaltered for the trial duration. * Have a carer who is willing and able to comply with all the requirements of the study, including the completion of the seizure diary and periodic device charging. Children enrolled in this study must not: * Have received prior deep brain stimulation insertion. * Have an active ('on') vagus nerve stimulator (or active within the six months prior to the baseline period). * Have had a change in their anti-seizure medication prescription or stopped their ketogenic diet within the last 4 weeks * Have started or made changes to the prescription of a ketogenic diet within the last 12-weeks * Have abnormal thalamic anatomy detected on imaging that would render DBS either unsafe or unfeasible. * Have a bleeding disorder(s). * Have a medical condition(s)/factor(s) that would increase their anaesthetic risk to an unacceptable level. * Have a nickel allergy. * Be pregnant.

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Conditions

The condition(s) this trial relates to.

epilepsy Lennox-Gastaut syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lennox-Gastaut syndrome (LGS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Great Ormond Street Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.