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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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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