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

Study Overview
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Brief Summary
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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.

Detailed Description
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In this randomised, sham-controlled trial, investigators will recruit forty patients with primary cranial-cervical dystonia to receive an implanted device for STN-DBS, and participants will be randomly assigned to receive either neurostimulation or sham stimulation for 3 months.The primary end point was the change from baseline to 3 months in the severity of symptoms, according to the Burke-Fahn-Marsden Dystonia Rating Scale. Two masked dystonia experts who unaware of treatment status will assess the severity of dystonia by reviewing standardised videos.Subsequently, all patients will receive open-label neurostimulation; blinded assessment will be repeated after 6 months of active treatment.

Official Title
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Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial

Conditions
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Dystonia

Intervention / Treatment
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* Procedure: Stimulation
* Procedure: Sham-stimulation


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation Group<br>Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months. | Procedure: Stimulation<br>* After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.<br>|
| Sham Comparator: Sham-stimulation Group<br>Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months. | Procedure: Sham-stimulation<br>* After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of motor and disability scores | Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D) | Baseline,3 months after surgery, 6 months after active stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | SF-36 | Baseline,3 months after surgery,6 months after active stimulation | 
| Depression | Beck Depression Inventory | Baseline,3 months after surgery,6 months after active stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep brain stimulation, Subthalamic Nucleus, dystonia