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

Surgery Clinical Trial

— FRANCE  

Official title:

Clinical and Medico-economical Assessment of Deep Brain Stimulation of the Anterior Nucleus of the Thalamus for the Treatment of Pharmacoresistant Partial Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076698
• Other study ID #: 1317 FRANCE
• Status: Completed
• Phase: Phase 3
• Start date: June 16, 2014
• Est. completion date: November 10, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is twofold:

1. Assess the clinical efficacy of DBS on epilepsy according to their number and severity at 1 year follow up.

2. Perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.

The study hypothesis is that thalamic DBS (neurostimulation of the anterior nucleus of the thalamus) will decrease significantly, the frequency (potentially 50% reduction in severe crises) of the most severe seizures, in at least 50% of patients who have drug-resistant partial epilepsy; and should also improve significantly the quality of life through a gain of independence in activities of daily life, the possible recovery of functional abilities, recovery of social or professional activities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patient with focal or multifocal epilepsy with or without secondary generalized seizure inoperable at the time of inclusion

• Failure of pharmacological therapies (pharmacoresistant epilepsy) for over 4 years (persistent seizures despite at least two anti-epileptic treatments used at the optimal dose for at least 2 years)

• Failure of vagus nerve stimulation, defined as the persistence of crises considered debilitating after 2 years of VNS's treatment

• VNS failure in a patient treated with VNS, for less than 2 years. with stop early due to the worsening crisis

• Intelligence quotient above 55

• Have the written consent of the legal representative for patients under guardianship and minors

• Affiliation to the french social security system or equivalent

• People who signed the consent form

• Seizure frequency at least 4 crisis / month on average for at least 3 months, about 12 crisis in 3 months objectified by the neurologist during visit pre-inclusion, and confirmed by the neurologist after 3 months of Baseline during the inclusion visit

Exclusion Criteria:

• Patient with a generalized epilepsy Immediately

• Patient with a simple partial seizures (subjective manifestations only)

• Patient with a cons-indication for MRI, a serious intercurrent disease, a progressive brain tumor

• Patient with a suicide risk of in the six months preceding the inclusion visit (score = 2 on item 10 of the Montgomery-Asberg Depression Rating Scale)

• Patient a surgical or anesthetic cons-indication

• Patient with anticoagulant or antiplatelet treatment in the long term

• Woman of childbearing potential without effective contraception, or pregnant or lactating

• People hospitalized without consent

• People deprived of freedom

• Patient currently participating in another clinical research, or who participated in a clinical study in the month preceding the pre-inclusion visit (except for any non-interventional research)

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsy
• Surgery

Intervention

Procedure:
• AN-DBS
Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment

Drug:
• Usual treatment
usual treatment of epilepsy Vagus nerve stimulation: maintained

Locations

Country	Name	City	State
France	University Hospital of Pellegrin	Bordeaux
France	University Hospital of Grenoble Michallon	Grenoble
France	University Hospital	Lille
France	University Hospital of Pierre Wertheimer	Lyon
France	University Hospital of la Timone	Marseille
France	University Hospital of Gui de Chauliac	Montpellier
France	University Hospital	Nancy
France	University Hospital Pasteur	Nice
France	Sainte Anne Hospital	Paris
France	University Hospital of La Pitié-Salpétrière	Paris
France	University Hospital of Pontchaillou	Rennes
France	University Hospital of Rangueil	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (4)

Chabardès S, Kahane P, Minotti L, Koudsie A, Hirsch E, Benabid AL. Deep brain stimulation in epilepsy with particular reference to the subthalamic nucleus. Epileptic Disord. 2002 Dec;4 Suppl 3:S83-93. — View Citation

Chabardès S, Minotti L, Chassagnon S, Piallat B, Torres N, Seigneuret E, Vercueil L, Carron R, Hirsch E, Kahane P, Benabid AL. [Basal ganglia deep-brain stimulation for treatment of drug-resistant epilepsy: review and current data]. Neurochirurgie. 2008 May;54(3):436-40. doi: 10.1016/j.neuchi.2008.02.039. Epub 2008 May 2. Review. French. — View Citation

Fisher R, Salanova V, Witt T, Worth R, Henry T, Gross R, Oommen K, Osorio I, Nazzaro J, Labar D, Kaplitt M, Sperling M, Sandok E, Neal J, Handforth A, Stern J, DeSalles A, Chung S, Shetter A, Bergen D, Bakay R, Henderson J, French J, Baltuch G, Rosenfeld W, Youkilis A, Marks W, Garcia P, Barbaro N, Fountain N, Bazil C, Goodman R, McKhann G, Babu Krishnamurthy K, Papavassiliou S, Epstein C, Pollard J, Tonder L, Grebin J, Coffey R, Graves N; SANTE Study Group. Electrical stimulation of the anterior nucleus of thalamus for treatment of refractory epilepsy. Epilepsia. 2010 May;51(5):899-908. doi: 10.1111/j.1528-1167.2010.02536.x. Epub 2010 Mar 17. — View Citation

Lim SN, Lee ST, Tsai YT, Chen IA, Tu PH, Chen JL, Chang HW, Su YC, Wu T. Electrical stimulation of the anterior nucleus of the thalamus for intractable epilepsy: a long-term follow-up study. Epilepsia. 2007 Feb;48(2):342-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of effectiveness of thalamic DBS on seizures severity	The main objective of the study is twofold : to assess the effectiveness of DBS on seizures according to their severity at 1 year follow up and to perform a cost-effectiveness analysis from the perspective of Medicare at 1 and 2 years.	2 years
Secondary	Cost-utility analysis from the perspective of Medicare	Perform a cost-utility analysis from the perspective of Medicare at 1 and 2 years.	2 years
Secondary	Comparison of the improvement of quality of life and overall neuropsychological impact	Compare the improvement of quality of life and overall neuropsychological impact at 1 and 2 years.	2 years
Secondary	Comparison the adverse effects (including depression)	Compare the adverse events (special focus on depression) at 1 and 2 years.	2 years
Secondary	Impact of th new therapeutic strategy on the hospital budget	Determine the impact on the hospital budget for the introduction of this therapeutic strategy.	2 years