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Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia

China40 participantsStarted 2015-09-15

Plain-language summary

Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin injections.This study is to establish whether subthalamic nucleus neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment. Investigators compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.

Who can participate

SexALL

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Inclusion criteria

✓. Clinical diagnosis of primary cranial-cervical dystonia: blepharospasm combined with dystonia of the lower facial muscles. Cervical muscles can be involved but did not dominate the clinical picture.
✓. Medical intractable：including various drugs and local botulinum toxin injections.
✓. patients deteriorated in activities of daily living and showed social withdrawal during the course of their disease as they suffered from apparent hyperkinesia of facial muscles and functional blindness secondary to severe blepharospasm.

Exclusion criteria

✕. All other topographical areas remained unaffected.
✕. Secondary causes will be excluded by standard cranial magnetic resonance imaging (MRI) scans.
✕. Cognitive impairment, dementia,severe psychiatric diseases as well as higher surgical risks due to comorbidities will also be exclusion criteria.

What they're measuring

Change of motor and disability scores

Timeframe: Baseline,3 months after surgery, 6 months after active stimulation

Trial details

NCT IDNCT02583074

SponsorBeijing Tiantan Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-31

Contact for this trial

Zhang Kai, MD

861067096767 zhangkai62035@163.com

View on ClinicalTrials.gov More Dystonia trials