Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia
STN-CCD
Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2015
CompletedFirst Submitted
Initial submission to the registry
September 23, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedMarch 20, 2018
March 1, 2018
3.3 years
September 23, 2015
March 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Quality of life
Baseline,3 months after surgery,6 months after active stimulation
Depression
Baseline,3 months after surgery,6 months after active stimulation
Other Outcomes (1)
Adverse event
3 months after surgery,6 months after active stimulation
Study Arms (2)
Stimulation Group
EXPERIMENTALPatients in 'Neurostimulation Group' will receive subthalamic nucleus deep brain stimulation for 3 months.
Sham-stimulation Group
SHAM COMPARATORPatients in 'Sham-stimulation Group' will receive sham stimulation of subthalamic nucleus for 3 months.
Interventions
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- All other topographical areas remained unaffected.
- Secondary causes will be excluded by standard cranial magnetic resonance imaging (MRI) scans.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Tiantan Hospitallead
- Peking Union Medical College Hospitalcollaborator
- The First Affiliated Hospital of Dalian Medical Universitycollaborator
- China-Japan Friendship Hospitalcollaborator
Study Sites (2)
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, 100050, China
Related Publications (5)
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.
PMID: 18439222RESULTLimotai 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.
PMID: 21553081RESULTReese 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.
PMID: 21312284RESULTOstrem 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.
PMID: 24440061RESULTCao 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.
PMID: 23861342RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Jian-guo, MD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD，MD
Study Record Dates
First Submitted
September 23, 2015
First Posted
October 21, 2015
Study Start
September 15, 2015
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
March 20, 2018
Record last verified: 2018-03