Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental Dystonia

German Parkinson Study Group (GPS)

Status and phase: Unknown; Phase 4

Conditions: Dystonia

Treatments: Device: Deep brain stimulation of the internal globus pallidus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00142259

15

Grant: 01 GI 0201 / 01 GI 0401

Details and patient eligibility

About

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.

Sex: All

Ages: 14 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind