DystoniaPhase 2NCT00169338
Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia
A Phase 2 study testing Deep brain stimulation in people with Dystonia, run by Marie-laure Welter at 1 site in France.
Trial summary
Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Deep brain stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jan 2014
- Phase
- Phase 2
- 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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Post-anoxic generalised dystonia
- Idiopathic non-generalised dystonia
- Disease duration > 1 year
Who cannot join
- Contraindication to magnetic resonance imaging (MRI)
- Mini-mental status (MMS) < 24
- Severe psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.
Read the detailed description
Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.
- Conditions
- Dystonia
- Being tested
- Deep brain stimulation
- Keywords
- Dystonia, deep brain stimulation, globus pallidus, Post-anoxic dystonia
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep brain stimulationProcedure or surgery
internal pallidal deep brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| deep brain stimulation | Experimental | Paladin deep brain stimulation Receives: Procedure: Deep brain stimulation |
| sham deep brain stimulation | Placebo comparator | no stimulation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie-laure Welter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marie-laure Welter, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Marie Vidailhet, MD, PhD, Study director, Hôpital Saint-Antoine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169338
- Sponsor's protocol ID
- P020918
- Status last verified
- Sep 2015
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia
- ClinicalTrials.gov ID
- NCT00169338
- Acronym / sponsor ID
- P020918
- Conditions
- Dystonia
- Keywords
- Dystonia, deep brain stimulation, globus pallidus, Post-anoxic dystonia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Marie-laure WelterUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 Sep 2005 (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.
Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.
Detailed description
Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep brain stimulation | Experimental | Procedure: Deep brain stimulationPaladin deep brain stimulation |
| sham deep brain stimulation | Placebo comparator | –no stimulation |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Post-anoxic generalised dystonia
- Idiopathic non-generalised dystonia
- Disease duration > 1 year
Key exclusion criteria (3 listed)
- Contraindication to magnetic resonance imaging (MRI)
- Mini-mental status (MMS) < 24
- Severe psychiatric disorder
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 |
|---|---|---|
| Deep brain stimulationinternal pallidal deep brain stimulation | Procedure or surgery | deep brain stimulation |
Primary outcome
Not reported in the source record.
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 15 Sep 2015.
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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.
Marie Vidailhet, MD, PhD study director
Hôpital Saint-Antoine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Deep brain stimulation in people with Dystonia, run by Marie-laure Welter 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 3 inclusion and 3 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 15 Sep 2015. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 15 Sep 2015.