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

March 17, 2018 updated by: Kai Zhang, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
        • Contact:
          • Zhang Jianguo, MD
          • Phone Number: 6767 8610-67096767
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
        • Contact:
          • Zhang Jianguo, MD
          • Phone Number: 6767 8610-67096767
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline,3 months after surgery, 6 months after active stimulation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Adverse event
Time Frame: 3 months after surgery,6 months after active stimulation
3 months after surgery,6 months after active stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Peking Union Medical College Hospital
China-Japan Friendship Hospital
The First Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Zhang Jian-guo, MD, Beijing Tiantan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 15, 2015

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 17, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYLX201305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dystonia

Clinical Trials on Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe