Focal DystoniaPhase 1CORDYSNCT00505323
Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Palliadal Lesion : Evaluation of Safety and Effectiveness
A Phase 1 study testing Implantation of neurostimulators and their auxiliary components in people with Focal Dystonia, run by University Hospital, Clermont-Ferrand.
Trial summary
Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Focal Dystonia
- What is being tested?
- Implantation of neurostimulators and their auxiliary components
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Jun 2011
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : >18 years and < 65 years
- Evolution time of dystonia > 1 year
- Clinical stability of dystonia = 1 year
- Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
- Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
- Stability of treatment >3 months
- Agreement of patients
- Affiliation to social security
Who cannot join
- Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
- Significant clinical and biological anomalies
- Disease or treatment in favour in bleeding
- Sever cognitive disorders
- Psychiatric evolutionary pathology
- Counter-indication during inclusion examination
Show all 9Show fewer
- Chirurgical counter-indication
- Pregnant women ou women who nurse
- Person who participate to an other study
About this study
Official title: Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness
Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage.
Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.
Read the detailed description
Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and Grenoble)
Study progress :
- 3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol.
- 15 days to 8 days before chirurgical intervention : inclusion visit.
- Operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters.
- 1 month after chirurgical intervention : checking that all is fine (detection of undesirable events)
- 2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position On or OFF
- 5 months after chirurgical intervention : Stimulators of all patients are stopped for one month whatever the group they belong.
- 6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On or OFF (cross over with the first period).
- 9 months to 13 months after chirurgical intervention: Stimulators of all patients are started for four months whatever the group they belong.
- 13 months after chirurgical intervention : study end
- Conditions
- Focal Dystonia
- Being tested
- Implantation of neurostimulators and their auxiliary components
- Keywords
- Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of neurostimulators and their auxiliary componentsDevice
Implantation neurostimulators and their auxiliary components :
Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale
Measured: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after
Secondary outcomes (1)
Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events.
Measured: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal DystoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Franck DURIF, Pr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505323
- Sponsor's protocol ID
- 2007-A00100-53
- Other IDs
- PHRC N 2007 DURIF
- Acronym
- CORDYS
- Status last verified
- Jul 2014
- First submitted
- 20 Jul 2007
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Premotor Cortex Stimulation for Treatment of Secondary Focal Dystonia With Striato Pallidal Lesion : Evaluation of Safety and Effectiveness
- ClinicalTrials.gov ID
- NCT00505323
- Acronym / sponsor ID
- CORDYS / 2007-A00100-53
- Conditions
- Focal Dystonia
- Keywords
- Cortex stimulation, Focal secondary Dystonia, Effectiveness, Quality of life improvement, Focal dystonias secondary to central grey nuclei lesions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jul 2007 (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.
Dystonia is a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures. This disease is very heterogeneous and can have many causes. Current treatments (drugs, pallidal stimulation) improve primary generalized dystonias; however they are ineffective for focal dystonias following brain damage.
Cortex stimulation is a present and effective technique used in the treatment of chronic pain and could represent an interesting strategy to treat focal dystonias. This is the aim of the present study.
Detailed description
Pilot study included 6 centres (Clermont-Ferrand, Bordeaux, Paris, Créteil, Lyon and Grenoble)
Study progress :
- 3 months to 1 month before chirurgical intervention : selection of patient that could be included in the protocol.
- 15 days to 8 days before chirurgical intervention : inclusion visit.
- Operating phase : under anaesthesia, implantation of the neurostimulator and its components, and adjustment of stimulation parameters.
- 1 month after chirurgical intervention : checking that all is fine (detection of undesirable events)
- 2 months to 5 months after chirurgical intervention: randomization (double blind): the stimulator is put on position On or OFF
- 5 months after chirurgical intervention : Stimulators of all patients are stopped for one month whatever the group they belong.
- 6 months to 9 months after chirurgical intervention: Stimulatiors are put on position On or OFF (cross over with the first period).
- 9 months to 13 months after chirurgical intervention: Stimulators of all patients are started for four months whatever the group they belong.
- 13 months after chirurgical intervention : study end
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age : >18 years and < 65 years
- Evolution time of dystonia > 1 year
- Clinical stability of dystonia = 1 year
- Secondary dystonia due to a focal lesion (vascular or anoxic) of central grey nuclei
- Inefficiency of others treatments (anticholinergic, benzodiazepine, neuroleptique, botulinum toxin, etc.)
Key exclusion criteria (9 listed)
- Significant heart vascular disease; significant respiratory, metabolic, renal or hepatic diseases
- Significant clinical and biological anomalies
- Disease or treatment in favour in bleeding
- Sever cognitive disorders
- Psychiatric evolutionary pathology
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 |
|---|---|---|
| Implantation of neurostimulators and their auxiliary componentsImplantation neurostimulators and their auxiliary components : Stimulateur KINETRA TM modèle 7428, Electrode Resume II modèle 3587A, Extension kit DBS 7482 | Device | – |
Primary outcome
Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale
Time frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after
1 secondary outcome
Evaluation of spasticity (Ashworth), of akinesy (Tapping score), of pain (EVA test), of quality of life (SF 36 scale) and of undesirable events.
Time frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Franck DURIF, Pr principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Implantation of neurostimulators and their auxiliary components in people with Focal Dystonia, run by University Hospital, Clermont-Ferrand.
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 8 inclusion and 9 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: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of dystonia by using the validated "Burke Fahn and Marsden (1985)" dystonia rating scale (time frame: before the chirurgical intervention and 2, 5, 6, 9 and 13 months after). 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 8 Jul 2014.