Validation of the Implantation of a New Electrode for the Treatment of Dystonia (MONOCONTACT)
Primary Purpose
Generalized Dystonia, Segmental Dystonia, Tardive Dystonia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Dystonia
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
Sites / Locations
- Chru Montpellier
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrode deep brain stimulation
Arm Description
Monocontact electrode deep brain stimulation
Outcomes
Primary Outcome Measures
Technical feasibility of new electrode implantation
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)
The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.
Secondary Outcome Measures
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)
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).
Full Information
NCT ID
NCT02509338
First Posted
July 20, 2015
Last Updated
May 18, 2018
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02509338
Brief Title
Validation of the Implantation of a New Electrode for the Treatment of Dystonia
Acronym
MONOCONTACT
Official Title
Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
The medical device arrived at expirationand it was not possible to have new one
Study Start Date
October 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Dystonia, Segmental Dystonia, Tardive Dystonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrode deep brain stimulation
Arm Type
Experimental
Arm Description
Monocontact electrode deep brain stimulation
Intervention Type
Device
Intervention Name(s)
Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
Intervention Description
Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia
Primary Outcome Measure Information:
Title
Technical feasibility of new electrode implantation
Description
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.
Time Frame
One year
Title
Safety of new electrode implantation (evaluated by the occurence of side effects)
Description
The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.
Time Frame
One year
Secondary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A CIF, MD, PhD
Organizational Affiliation
CHRU Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chru Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Learn more about this trial
Validation of the Implantation of a New Electrode for the Treatment of Dystonia
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