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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Beijing Tiantan Hospital

Current Primary Outcome: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life [ Time Frame: Baseline,3 months after surgery,6 months after active stimulation ]
    SF-36
  • Depression [ Time Frame: Baseline,3 months after surgery,6 months after active stimulation ]
    Beck Depression Inventory


Original Secondary Outcome: Same as current

Information By: Beijing Tiantan Hospital

Dates:
Date Received: September 23, 2015
Date Started: September 2015
Date Completion: December 2017
Last Updated: October 20, 2015
Last Verified: October 2015