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

Conditions

Dystonia

Keywords

deep brain stimulation, internal globus pallidus, dystonia

Brief 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.

Frank Steigerwald, Anna Kirsch, Andrea A. Kühn, Andreas Kupsch, Joerg Mueller et al. (17 authors)

Neurological Research and Practice2019-09-249 citations

10.1186/s42466-019-0032-2

Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial.

Volkmann J, Wolters A, Kupsch A, Müller J, Kühn AA, Schneider GH, Poewe W, Hering S, Eisner W, Müller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R, DBS study group for dystonia.

2012-11-01264 citations

10.1016/s1474-4422(12)70257-0

Pallidal deep-brain stimulation in primary generalized or segmental dystonia.

Kupsch A, Benecke R, Müller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Müller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J, Deep-Brain Stimulation for Dystonia Study Group.

2006-11-01657 citations

10.1056/nejmoa063618

Interventions

DEVICEDeep brain stimulation of the internal globus pallidus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

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

Secondary

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

Countries

Austria, Germany

Outcome results

None listed