Generalized DystoniaMONOCONTACTNCT02509338
Validation of the Implantation of a New Electrode for the Treatment of Dystonia
A study testing Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm) in people with Generalized Dystonia and Segmental Dystonia, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Generalized Dystonia, Segmental Dystonia, Tardive Dystonia
- What is being tested?
- Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- Insurance affiliation
- Follow-up possible for 12 months
- Available insurance for the operated patient
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
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.
Read the 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
- Being tested
- Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)
- Medical subject headings
- Tardive Dyskinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)Device
Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia
| Study group | Role | What they receive |
|---|---|---|
| Electrode deep brain stimulation | Experimental | Monocontact electrode deep brain stimulation Receives: Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
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.
Measured: One year
Secondary outcomes (1)
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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: The medical device arrived at expirationand it was not possible to have new one
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized DystoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura A CIF, MD, PhD, Principal investigator, CHRU Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509338
- Sponsor's protocol ID
- 9053
- Acronym
- MONOCONTACT
- Status last verified
- May 2018
- First submitted
- 20 Jul 2015
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Electrode Internal Globus Pallidum Deep Brain Stimulation Lead Implantation for Treatment of Dystonia
- ClinicalTrials.gov ID
- NCT02509338
- Acronym / sponsor ID
- MONOCONTACT / 9053
- Conditions
- Generalized Dystonia, Segmental Dystonia, Tardive Dystonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The medical device arrived at expirationand it was not possible to have new one
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrode deep brain stimulation | Experimental | Device: Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)Monocontact electrode deep brain stimulation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- No possibility for clinical follow-up
- Acquired dystonia except for tardive dystonia
- MRI or generalized anesthesia contraindicated
- Anticoagulant treatment or antiaggregant treatment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Electrode deep brain stimulation |
Primary outcome
Technical feasibility of new electrode implantation
Time frame: 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)
Time frame: One year
The safety of the implantation is evaluated by the occurence of side effects after the implatation and along the follow-up.
1 secondary outcome
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)
Time frame: One year
Results and safety
The study was stopped early (reason given: The medical device arrived at expirationand it was not possible to have new one). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A CIF, MD, PhD principal investigator
CHRU Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm) in people with Generalized Dystonia and Segmental Dystonia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The medical device arrived at expirationand it was not possible to have new one). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of new electrode implantation (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.