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

Dystonia Clinical Trial

— STN-CCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583074
• Other study ID #: ZYLX201305
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2015
• Last updated: March 17, 2018
• Start date: September 15, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: Beijing Tiantan Hospital
• Contact: Zhang Kai, MD
• Phone: 861067096767
• Email: zhangkai62035[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Torticollis

Intervention

Procedure:
• Stimulation
After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
• Sham-stimulation
After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital Affiliated to Capital Medical University	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	China-Japan Friendship Hospital, Peking Union Medical College Hospital, The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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: — View 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. — View Citation

Reese R, Gruber D, Schoenecker T, Bäzner 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 d — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse event		3 months after surgery,6 months after active stimulation
Primary	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	Quality of life	SF-36	Baseline,3 months after surgery,6 months after active stimulation
Secondary	Depression	Beck Depression Inventory	Baseline,3 months after surgery,6 months after active stimulation