Clinical trial NCT02509338: Validation of the Implantation of a New Electrode for the Treatment of Dystonia
Official title: Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Generalized Dystonia
Segmental Dystonia
Tardive Dystonia
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of the trial is to study the technical feasibility of the implantation of a new electrode Monocontact deep brain stimulation electrode in dystonia.

Detailed description: Deep brain stimulation (DBS) is a validated therapy for treating dystonia and other movement disorders. The main therapeutical target used for treating dystonic syndromes is the internal globus pallidum (GPi). Given the morphology and the topography of this nucleus and, based on the experience of an efficient therapy by using only one or two contacts out of the available four contacts of the standard DBS lead, we designed two new electrodes, one one contact-electrode and one two contact-electrodes, with the aim to limit side effects related to internal globus pallidum DBS and to provide a more homogeneous electric field around the electrode within the GPi and maintaining the same therapeutical outcome.

The main objective of the trial is to study the technical feasibility of the implantation of a new one contact-electrode (Monopolar DBS Lead Model 09064-40cm) for treating isolated generalized/segmental dystonia or tardive dystonia.

The second main objective of the study is to assess the safety of the implantation of the new device.

The secondary objective is to explore the therapeutical effect of DBS using the new monocontact electrode and to study the electrical field generated around the monocontact electrode within the GPi.

The study is prospective and patients are recruited from a Tertiary Movement Disorders Clinic. Seven subjects will be recruited for the study.

Eligibility criteria: Inclusion Criteria:

* Age superior to 18 years and inferior to 65 years
* Generalized or segmental isolated dystonia or tardive dystonia
* Diagnosis is based on history, clinical examination, check-up without abnormalities and normal brain MRI allowing exclusion of secondary and degenerative dystonias
* Unsufficient response to pharmacological treatment (improvement \< 30/% on clinical dystonia scales)
* No comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial
* Consent of the patient
* Insurance affiliation
* Follow-up possible for 12 months
* Available insurance for the operated patient

Exclusion Criteria:

* No possibility for clinical follow-up
* Acquired dystonia except for tardive dystonia
* MRI or generalized anesthesia contraindicated
* Anticoagulant treatment or antiaggregant treatment
* Pregnancy
* Ongoing participation to another clinical trial
* Guardianship or Trusteeship
* Person deprived of liberty

Primary outcomes:
measure: Technical feasibility of new electrode implantation
timeFrame: One year
measure: Safety of new electrode implantation (evaluated by the occurence of side effects)
timeFrame: One year
Secondary outcomes:
measure: clinical effect of deep brain stimulation using one contact-electrodes (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale)
timeFrame: One year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Chru Montpellier
Study officials:
affiliation: CHRU Montpellier
name: Laura A CIF, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: