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Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia (STN-CCD)

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ClinicalTrials.gov Identifier: NCT02583074
Recruitment Status : Recruiting
First Posted : October 21, 2015
Last Update Posted : March 20, 2018
Sponsor:
Collaborators:
Peking Union Medical College Hospital
The First Affiliated Hospital of Dalian Medical University
China-Japan Friendship Hospital
Information provided by (Responsible Party):
Kai Zhang, Beijing Tiantan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Dystonia Procedure: Stimulation Procedure: Sham-stimulation Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial
Study Start Date : September 15, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Stimulation Group
Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.
Procedure: Stimulation
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.

Sham Comparator: Sham-stimulation Group
Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.
Procedure: Sham-stimulation
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.




Primary Outcome Measures :
  1. Change of motor and disability scores [ Time Frame: Baseline,3 months after surgery, 6 months after active stimulation ]
    Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D)


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Baseline,3 months after surgery,6 months after active stimulation ]
    SF-36

  2. Depression [ Time Frame: Baseline,3 months after surgery,6 months after active stimulation ]
    Beck Depression Inventory


Other Outcome Measures:
  1. Adverse event [ Time Frame: 3 months after surgery,6 months after active stimulation ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Medical intractable:including various drugs and local botulinum toxin injections.
  3. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583074


Contacts
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Contact: Zhang Kai, MD 861067096767 zhangkai62035@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Zhang Jianguo, MD    8610-67096767 ext 6767      
Contact: Zhang Kai, MD    8610-67096767 ext 6767    zhangkai62035@sina.com   
China
Beijing Tiantan Hospital Affiliated to Capital Medical University Recruiting
Beijing, China, 100050
Contact: Zhang Jianguo, MD    8610-67096767 ext 6767      
Contact: Zhang Kai, MD    8610-67096767 ext 6767    zhangkai62035@sina.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Peking Union Medical College Hospital
The First Affiliated Hospital of Dalian Medical University
China-Japan Friendship Hospital
Investigators
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Principal Investigator: Zhang Jian-guo, MD Beijing Tiantan Hospital

Publications of Results:
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Responsible Party: Kai Zhang, PhD,MD, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02583074     History of Changes
Other Study ID Numbers: ZYLX201305
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kai Zhang, Beijing Tiantan Hospital:
deep brain stimulation
Subthalamic Nucleus
dystonia
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases