Refractory EpilepsyNCT04771065
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy
An observational study of Refractory Epilepsy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Refractory Epilepsy
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 29 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients extracted from our prospective database, who have been surgically treated between 2010 and 2019 for refractory epilepsy by deep brain stimulation (DBS) of the anterior thalamic nucleus using microendoscopy. All patients had a minimum follow up of 1 year. Refractory epilepsy was defined as failure of at least 3 anti-epileptic drugs (AEDs) to produce adequate seizure control
Who may be able to join
- adult patients
- treated between 2010 and 2019 for refractory epilepsy by DBS of the anterior nucleus os the thalamus using microendoscopy
- minimum follow-up of 1-year
- refractory epilepsy defined as failure of at least 3 antiepileptic drugs
Who cannot join
- age < 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Gaëtan Poulen, MD, 467337262 ext. 33, g-poulen@chu-montpellier.fr
About this study
Official title: Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy
Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.
- Conditions
- Refractory Epilepsy
- Keywords
- epilepsy, deep brain stimulation, thalamus, endoscopy, stereotaxy
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of hemorraghic complication
Absence of hemorraghic complication on post operative MRI
Measured: 1 day
Secondary outcomes (3)
responder rate
50%-responder rate (on seizures)
Measured: 1 year
responder rate
50%-responder rate (on seizures)
Measured: 2 years
responder rate
50%-responder rate (on seizures)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion29 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëtan Poulen, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771065
- Sponsor's protocol ID
- RECHMPL21_0106
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy
- ClinicalTrials.gov ID
- NCT04771065
- Acronym / sponsor ID
- RECHMPL21_0106
- Conditions
- Refractory Epilepsy
- Keywords
- epilepsy, deep brain stimulation, thalamus, endoscopy, stereotaxy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 29 Dec 2021 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deep Brain Stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been proposed in patients with severe intractable epilepsy. When used, the transventricular approach increases the risk of bleeding due the anatomy around the entry point in the thalamus. To avoid such a complication, the investigators used a transventricular microendoscopic technique.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients extracted from our prospective database, who have been surgically treated between 2010 and 2019 for refractory epilepsy by deep brain stimulation (DBS) of the anterior thalamic nucleus using microendoscopy. All patients had a minimum follow up of 1 year. Refractory epilepsy was defined as failure of at least 3 anti-epileptic drugs (AEDs) to produce adequate seizure control
Key inclusion criteria (4 listed)
- adult patients
- treated between 2010 and 2019 for refractory epilepsy by DBS of the anterior nucleus os the thalamus using microendoscopy
- minimum follow-up of 1-year
- refractory epilepsy defined as failure of at least 3 antiepileptic drugs
Key exclusion criteria (1 listed)
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absence of hemorraghic complication
Time frame: 1 day
Absence of hemorraghic complication on post operative MRI
3 secondary outcomes
responder rate
Time frame: 1 year
responder rate
Time frame: 2 years
responder rate
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaëtan Poulen, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaëtan Poulen, MD (467337262 ext. 33, g-poulen@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of hemorraghic complication (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.