- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272246
Bilateral Internal Pallidum Stimulation in Primary Generalized Dystonia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design and methods:
This is a randomised, double-blind, placebo-controlled, multicentre study comparing the effect of bilateral DBS of the GPi with placebo in patients with invalidating primary generalized dystonia. After inclusion in the study (see in/exclusioncriteria), a preoperative formal baseline assessment is performed. Within six weeks after the inclusion the patients undergo the stereotactic implantation of the stimulation equipment in the GPi. Immediately after surgery the patients are randomly allocated to direct stimulation (treatment group) or delayed stimulation (control group), in which the stimulator will se switched on 0 Volt before discharge from the hospital by an independent neurologist or neurosurgeon. The patients in both groups are able to control whether the stimulation is active (>0 Volt) or not. In this way the patients and the assessors are blinded. In each centre the postoperative care of the patients will take place according to a stratified stimulation parameter protocol which assures comparable information in both groups. Six months postoperatively, the first formal outcome assessment is performed by the same blinded assessor. After completion of this assessment the stimulators in the control group are activated by an independent neurologist or neurosurgeon. From this moment, all 24 patients have active DBS. However, the patients and blinded assessor remain unaware of the result of the randomisation. All patients are followed for another six months after which the second outcome assessment is made by the same assessor. Four Dutch centres experienced in DBS have agreed to participate in the study. It is estimated that each centre will include at least 4 patients. Because these centra are geographically spread over the country patients can be operated and controlled nearby.
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Elisabeth MJ Foncke, MD
- Phone Number: 58966 0031205669111
- Email: e.m.foncke@amc.uva.nl
Study Contact Backup
- Name: Hans Speelman, MD,PhD
- Phone Number: 63963 0031205669111
- Email: j.d.speelman@amc.uva.nl
Study Locations
-
-
-
Amsterdam, Netherlands, 1100 DD
- Recruiting
- Department of Neurology, Movement Disorders Center
-
Contact:
- Elisabeth MJ Foncke, MD
- Phone Number: 58966 0031205669111
- Email: e.m.foncke@amc.uva.nl
-
Principal Investigator:
- Elisabeth MJ Foncke, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Invalidating primary generalized dystonia (BFMDRS-motor part >= 35)
- Disease duration >= 5 yrs
- Age at surgery between 12 and 60
- Insufficient improvement with pharmacological and physical therapy
- Signed informed consent, for patients < 19 yrs of age a written consent of the parent(s) or caretaker(s) is needed.
Exclusion Criteria:
- Mental retardation or dementia (MMSE <24)
- Depressive state (HADS>21)
- History of former stereotactic brain surgery
- Severe brain atrophy
- General surgical contraindications, such as uncontrolled hypertension or diabetes mellitus, cardiovascular or pulmonary risks, disturbances of bloodclotting.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
change in BFMDRS-motor score from baseline to six months after stimulation equipment implantation
|
Secondary Outcome Measures
Outcome Measure |
---|
BFMDRS-disability score
|
MOS-SF-36 (Medical Outcome Scale)
|
GOS (Global Outcome Scale)
|
Neuropsychological and neuropsychiatric validated scales
|
Questionnaire designed for the registration of the number and extent of morbidity due to the surgical
|
procedure, stimulation equipment and active stimulation
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Hans Speelman, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DYSPAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dystonia
-
University of Texas Southwestern Medical CenterMassachusetts General HospitalRecruitingDystonia | Dystonia; Idiopathic | Dystonia, Primary | Dystonia, Secondary | Dystonia, Familial | Dystonia Disorder | Dystonias, Sporadic | Dystonia; Orofacial | Dystonia Lenticularis | Dystonia, Paroxysmal | Dystonia 6 | Dystonia 5 | Dystonia 8 | Dystonia 9 | Dystonia 19 | Dystonia 10 | Dystonia 11 | Dystonia 20 | Dystonia 12 | Dystonia... and other conditionsUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompletedCervical Dystonia, PrimaryFrance
-
Duke UniversityAmerican Academy of NeurologyNot yet recruitingIsolated Focal Hand DystoniaUnited States
-
University Hospital, MontpellierTerminatedSpasticity | Isolated Cervical Dystonia | Complex DystoniaFrance
-
National Institute of Neurological Disorders and...Active, not recruitingDystonia | Focal Dystonia | Musician's DystoniaUnited States
-
University of FloridaBachmann Strauss Dystonia & Parkinson Foundation, Inc.Completed
-
University Hospital, MontpellierTerminatedTardive Dystonia | Generalized Dystonia | Segmental DystoniaFrance
-
Institut National de la Santé Et de la Recherche...Assistance Publique - Hôpitaux de ParisNot yet recruiting
-
University of Colorado, DenverCompleted
-
National Institute of Neurological Disorders and...Completed
Clinical Trials on deep brain stimulation of the internal globus pallidus
-
German Parkinson Study Group (GPS)Medtronic; Competence Network on Parkinson's DiseaseUnknownDystoniaGermany, Austria
-
University Hospital Inselspital, BerneBoston Scientific CorporationTerminatedParkinson Disease | Movement Disorders | Neurodegenerative Disorders | Central Nervous System Disease | Basal Ganglia DiseaseSwitzerland
-
Beijing Tiantan HospitalPeking University People's Hospital; Peking Union Medical College Hospital; Chinese... and other collaboratorsRecruitingDeep Brain Stimulation | Craniofacial DystoniaChina
-
Jorge Gonzalez-MartinezNot yet recruitingCardiovascular Diseases | Stroke | Central Nervous System Diseases | Nervous System Diseases | Brain DiseaseUnited States
-
University of California, Los AngelesRecruiting
-
Oregon Health and Science UniversityRecruiting
-
University of CologneGerman Research FoundationCompleted
-
Jonathan JagidUnited States Department of DefenseCompletedPain | Autonomic DysreflexiaUnited States
-
University Hospital TuebingenAbbottActive, not recruitingParkinson DiseaseGermany
-
Hospital San Carlos, MadridUnknown