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

Primary Purpose

Dystonia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stimulation
Sham-stimulation
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia focused on measuring deep brain stimulation, Subthalamic Nucleus, dystonia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting
  • Beijing Tiantan Hospital Affiliated to Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stimulation Group

Sham-stimulation Group

Arm Description

Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.

Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.

Outcomes

Primary Outcome Measures

Change of motor and disability scores
Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D)

Secondary Outcome Measures

Quality of life
SF-36
Depression
Beck Depression Inventory

Full Information

First Posted
September 23, 2015
Last Updated
March 17, 2018
Sponsor
Beijing Tiantan Hospital
Collaborators
Peking Union Medical College Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02583074
Brief Title
Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia
Acronym
STN-CCD
Official Title
Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2015 (undefined)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Peking Union Medical College Hospital, The First Affiliated Hospital of Dalian Medical University, China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia
Keywords
deep brain stimulation, Subthalamic Nucleus, dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stimulation Group
Arm Type
Experimental
Arm Description
Patients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.
Arm Title
Sham-stimulation Group
Arm Type
Sham Comparator
Arm Description
Patients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.
Intervention Type
Procedure
Intervention Name(s)
Stimulation
Intervention Description
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
Intervention Type
Procedure
Intervention Name(s)
Sham-stimulation
Intervention Description
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.
Primary Outcome Measure Information:
Title
Change of motor and disability scores
Description
Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D)
Time Frame
Baseline,3 months after surgery, 6 months after active stimulation
Secondary Outcome Measure Information:
Title
Quality of life
Description
SF-36
Time Frame
Baseline,3 months after surgery,6 months after active stimulation
Title
Depression
Description
Beck Depression Inventory
Time Frame
Baseline,3 months after surgery,6 months after active stimulation
Other Pre-specified Outcome Measures:
Title
Adverse event
Time Frame
3 months after surgery,6 months after active stimulation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Kai, MD
Phone
861067096767
Email
zhangkai62035@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Jian-guo, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Jianguo, MD
Phone
8610-67096767
Ext
6767
First Name & Middle Initial & Last Name & Degree
Zhang Kai, MD
Phone
8610-67096767
Ext
6767
Email
zhangkai62035@sina.com
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Jianguo, MD
Phone
8610-67096767
Ext
6767
First Name & Middle Initial & Last Name & Degree
Zhang Kai, MD
Phone
8610-67096767
Ext
6767
Email
zhangkai62035@sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18439222
Citation
Skogseid IM. Pallidal deep brain stimulation is effective, and improves quality of life in primary segmental and generalized dystonia. Acta Neurol Scand Suppl. 2008;188:51-5. doi: 10.1111/j.1600-0404.2008.01032.x.
Results Reference
result
PubMed Identifier
21553081
Citation
Limotai N, Go C, Oyama G, Hwynn N, Zesiewicz T, Foote K, Bhidayasiri R, Malaty I, Zeilman P, Rodriguez R, Okun MS. Mixed results for GPi-DBS in the treatment of cranio-facial and cranio-cervical dystonia symptoms. J Neurol. 2011 Nov;258(11):2069-74. doi: 10.1007/s00415-011-6075-0. Epub 2011 May 7.
Results Reference
result
PubMed Identifier
21312284
Citation
Reese R, Gruber D, Schoenecker T, Bazner H, Blahak C, Capelle HH, Falk D, Herzog J, Pinsker MO, Schneider GH, Schrader C, Deuschl G, Mehdorn HM, Kupsch A, Volkmann J, Krauss JK. Long-term clinical outcome in meige syndrome treated with internal pallidum deep brain stimulation. Mov Disord. 2011 Mar;26(4):691-8. doi: 10.1002/mds.23549. Epub 2011 Feb 10.
Results Reference
result
PubMed Identifier
24440061
Citation
Ostrem JL, Markun LC, Glass GA, Racine CA, Volz MM, Heath SL, de Hemptinne C, Starr PA. Effect of frequency on subthalamic nucleus deep brain stimulation in primary dystonia. Parkinsonism Relat Disord. 2014 Apr;20(4):432-8. doi: 10.1016/j.parkreldis.2013.12.012. Epub 2014 Jan 5.
Results Reference
result
PubMed Identifier
23861342
Citation
Cao C, Pan Y, Li D, Zhan S, Zhang J, Sun B. Subthalamus deep brain stimulation for primary dystonia patients: a long-term follow-up study. Mov Disord. 2013 Nov;28(13):1877-82. doi: 10.1002/mds.25586. Epub 2013 Jul 16.
Results Reference
result

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

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