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

NCT ID: NCT02509338

Last Updated: 2018-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-12-31

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.

Conditions

Generalized Dystonia; Segmental Dystonia; Tardive Dystonia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electrode deep brain stimulation

Monocontact electrode deep brain stimulation

Group Type: EXPERIMENTAL

Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)

Intervention Type: DEVICE

Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia

Interventions

Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)

Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A CIF, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Montpellier

Locations

Chru Montpellier

Montpellier, , France

Countries

France

Other Identifiers

9053

Identifier Type: -

Identifier Source: org_study_id