Bilateral Internal Pallidum Stimulation in Primary Generalized Dystonia
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ClinicalTrials.gov Identifier: NCT00272246 |
Recruitment Status : Unknown
Verified January 2006 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Recruiting
First Posted : January 5, 2006
Last Update Posted : January 5, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dystonia Primary Generalized Dystonia | Procedure: deep brain stimulation of the internal globus pallidus | Phase 2 Phase 3 |
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 : | Interventional (Clinical Trial) |
Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | February 2005 |
Study Completion Date : | December 2007 |
- change in BFMDRS-motor score from baseline to six months after stimulation equipment implantation
- 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

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Ages Eligible for Study: | 12 Years to 60 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272246
Contact: Elisabeth MJ Foncke, MD | 0031205669111 ext 58966 | e.m.foncke@amc.uva.nl | |
Contact: Hans Speelman, MD,PhD | 0031205669111 ext 63963 | j.d.speelman@amc.uva.nl |
Netherlands | |
Department of Neurology, Movement Disorders Center | Recruiting |
Amsterdam, Netherlands, 1100 DD | |
Contact: Elisabeth MJ Foncke, MD 0031205669111 ext 58966 e.m.foncke@amc.uva.nl | |
Principal Investigator: Elisabeth MJ Foncke, MD |
Study Chair: | Hans Speelman, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
ClinicalTrials.gov Identifier: | NCT00272246 |
Other Study ID Numbers: |
DYSPAS |
First Posted: | January 5, 2006 Key Record Dates |
Last Update Posted: | January 5, 2006 |
Last Verified: | January 2006 |
dystonia |
Dystonia Dystonic Disorders Dyskinesias Neurologic Manifestations |
Nervous System Diseases Movement Disorders Central Nervous System Diseases |