Trials / Unknown
UnknownNCT02583074
Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia
Subthalamic Deep Brain Stimulation in Patients With Medication-Refractory Primary Cranial-Cervical Dystonia: A Randomised, Sham-controlled Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Beijing Tiantan Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Stimulation | After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months. |
| PROCEDURE | Sham-stimulation | After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months. |
Timeline
- Start date
- 2015-09-15
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2015-10-21
- Last updated
- 2018-03-20
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02583074. Inclusion in this directory is not an endorsement.