NCT04771065

Brief 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. To avoid such a complication, the investigators used a transventricular microendoscopic technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2021

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 22, 2021

Last Update Submit

February 22, 2021

Conditions

Refractory Epilepsy

Keywords

epilepsydeep brain stimulationthalamusendoscopystereotaxy

Outcome Measures

Primary Outcomes (1)

  • Absence of hemorraghic complication

    Absence of hemorraghic complication on post operative MRI

    1 day

Secondary Outcomes (3)

  • responder rate

    1 year

  • responder rate

    2 years

  • responder rate

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • \- age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Drug Resistant EpilepsyEpilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Gaëtan Poulen, MD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaëtan Poulen, MD

CONTACT

467337262g-poulen@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 29, 2021

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations

FR(1)