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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02583074

Acronym

STN-CCD

Enrollment

Registered

2015-10-21

Start date

2015-09-15

Completion date

2018-12-31

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dystonia

Keywords

deep brain stimulation, Subthalamic Nucleus, dystonia

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 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.

Interventions

PROCEDUREStimulation

After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.

PROCEDURESham-stimulation

After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of motor and disability scores	Baseline,3 months after surgery, 6 months after active stimulation	Burke-Fahn-Marsden Dystonia Rating Scale (movement and disability scores, BFMDRSM/D)

Secondary

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

Other

Measure	Time frame
Adverse event	3 months after surgery,6 months after active stimulation

Countries

China

Contacts

Primary ContactZhang Kai, MD

zhangkai62035@163.com861067096767

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026