Validation of the Implantation of a New Electrode for the Treatment of Dystonia

Not Applicable

Terminated

• Conditions: Segmental Dystonia; Tardive Dystonia; Generalized Dystonia
• Interventions: Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)

• Registration Number: NCT02509338
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-28
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electrode deep brain stimulation	Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)	Monocontact electrode deep brain stimulation

Primary Outcome Measures

Name	Time	Method
Technical feasibility of new electrode implantation	One year	The feasibility of the implantation is evaluated by stereotaxic frame placement, site of incision, burr hole size and location, technique for insertion, connection with the extension cables to the neurostimulator, measure of the impedances, duration of the surgery, MRI control for lead position, comparison of the artefacts of the leads with the artefacts of the standard electrodes.
Safety of new electrode implantation (evaluated by the occurence of side effects)	One year	The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.

Secondary Outcome Measures

Name	Time	Method
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)	One year	Clinical change as measured by the decrease of the motor and disability of the patient (Burke Fahn Marsden's dystonia rating scale and the Toronto Western Spasmodic Torticollis Rating Scale).

Trial Locations

Locations (1)

Chru Montpellier; 🇫🇷 Montpellier, France