Overview

This trial is active, not recruiting.

Condition dystonia
Treatment deep brain stimulation of the internal globus pallidus
Phase phase 4
Sponsor German Parkinson Study Group (GPS)
Collaborator Medtronic
Start date October 2002
End date August 2009
Trial size 40 participants
Trial identifier NCT00142259, 15, Grant: 01 GI 0201 / 01 GI 0401

Summary

The purpose of this study is to evaluate the efficacy and safety of bilateral deep brain stimulation of the internal globus pallidus for treating idiopathic generalized or severe segmental dystonia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
relative change of the individual Burk-Fahn-Marsden-Dystonia motor score 3 months after treatment compared to baseline
time frame:

Secondary Outcomes

Measure
relative change of the individual Burk-Fahn-Marsden-Dystonia ADL score 3 months after treatment compared to baseline
time frame:

Eligibility Criteria

Male or female participants from 14 years up to 75 years old.

Inclusion Criteria: - diagnosis of idiopathic multifocal, segmental or generalised dystonia - duration of disease > 5 years - age between 14 and 75 years - relevant disability in activities of daily living despite optimal drug treatment - informed consent signed by the patient - For adolescents between 14 and 18 years: an additional informed consent signed by a legal guardian is necessary Exclusion Criteria: - Mattis-Score < 120 - BDI > 25 - previous stereotactic brain surgery - severe brain atrophy - increased bleeding risk - immunosuppression and increased risk of infection - relevant cerebrovascular disease - psychiatric disorders, which might interfere with the cooperation in the study - other contraindications for surgery

Additional Information

Official title Randomisierte, Doppelblinde Langzeitstudie Zur Klinischen Wirksamkeit Der Bilateralen Globus Pallidus Internus-Stimulation Bei Idiopathischer Generalisierter Oder Segmentaler Dystonie
Principal investigator Jens Volkmann, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2006.
Information provided to ClinicalTrials.gov by German Parkinson Study Group (GPS).