Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Intractable Epilepsy

Refractory Epilepsy Clinical Trial

Official title:

Microendoscopic Transventricular Deep Brain Stimulation of the Anterior Nucleus of the Thalamus as a Safe and Efficient Treatment in Intractable Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771065
• Other study ID #: RECHMPL21_0106
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Montpellier
• Contact: Gaëtan Poulen, MD
• Phone: 467337262
• Email: g-poulen[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 29, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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

Exclusion criteria:

• age < 18 years

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of hemorraghic complication	Absence of hemorraghic complication on post operative MRI	1 day
Secondary	responder rate	50%-responder rate (on seizures)	1 year
Secondary	responder rate	50%-responder rate (on seizures)	2 years
Secondary	responder rate	50%-responder rate (on seizures)	5 years