Bilateral Internal Pallidum Stimulation in Primary Generalized Dystonia

NCT00272246 | Unknown Phase 2

• 1 other identifier: DYSPAS
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Primary generalized dystonia, also called idiopathic torsion dystonia or dystonia musculorum deformans is a disabling neurological condition which usually starts in childhood, mostly in a lower limb and spreads to other body parts as the disease progresses. Medical treatment is usually ineffective and most patients become wheelchair bound or even bedridden. Recently several case series and one RCT reported favourable results of bilateral deep brain stimulation (DBS) of the globus pallidus internus (GPi) for primary generalized dystonias. However, the number of patients treated with bilateral GPi stimulation is still limited. Therefore, we propose a RCT to investigate whether bilateral DBS of the GPi is an effective and safe treatment in patients with primary generalized dystonia.

Conditions

Dystonia; Primary Generalized Dystonia

Keywords

dystonia

Outcome Measures

Primary Outcomes (1)

• change in BFMDRS-motor score from baseline to six months after stimulation equipment implantation

Secondary Outcomes (6)

• 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

Interventions

deep brain stimulation of the internal globus pallidus PROCEDURE

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Princess Beatrix Muscle Foundation: collaborator

Study Sites (1)

Department of Neurology, Movement Disorders Center

Amsterdam, 1100 DD, Netherlands

RECRUITING

Related Publications (1)

• Foncke EM, Speelman JD. [Primary generalized dystonia and deep brain stimulation: a randomized, placebo-controlled, double-blind, multicentre study]. Ned Tijdschr Geneeskd. 2005 May 14;149(20):1123-4. Dutch.

  PMID: 15932141 BACKGROUND

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Speelman, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

Central Study Contacts

Elisabeth MJ Foncke, MD

CONTACT

0031205669111; e.m.foncke@amc.uva.nl

Hans Speelman, MD,PhD

CONTACT

0031205669111; j.d.speelman@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2006
• First Posted: January 5, 2006
• Study Start: February 1, 2005
• Study Completion: December 1, 2007
• Last Updated: January 5, 2006

Record last verified: 2006-01

Locations

NL (1)