Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05715138, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaContact: Zhiqi Mao, Ph.DNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT05715138
- Record updated
- 21 July 2023
- Original description
Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Deep Brain Stimulation (DBS) targeting on globus pallidus internus (GPi) or subthalamic nucleus (STN) has been proved to be a safe and effective strategy for primary cervical dystonia, even for those medically refractory cases. However, the question of which target is better has not been clarified.Read full original descriptionShow less
A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia（the PASTS-CD Study）
Cervical dystonia (CD), also known as spasmodic torticollis, is a type of focal dystonia, mainly manifesting as involuntary head turning or tilting, or holding a twisted posture. Although it can be alleviated by injection of botulinum toxin, the effect is temporary so that patients require multiple injections. Deep Brain Stimulation (DBS) targeting on globus pallidus internus (GPi) or subthalamic nucleus (STN) has been proved to be a safe and effective strategy for primary cervical dystonia, even for those medically refractory cases. However, the question of which target is better has not been clarified.
Therefore, the invstigators design this randomized and controlled trial, aiming to compare the differences between GPi-DBS and STN-DBS for cervical dystonia in the improvement of symptoms , quality of life, mental status, cognitive status, as well as in stimulation parameters and adverse effects. The invstigators hypothesize that STN-DBS will outperform GPi-DBS at short-term follow-up, while the superiority will disappear and the efficacy of the two group will become similar at long-term follow-up.
Inclusion: Diagnosed as idiopathic or hereditary isolated CD; Severe functional impairment; Oral medication and injection of botulinum toxin become ineffective (> 3 months since last injection), or refuse to adopt botulinum toxin injection; No secondary causes of CD; Age 18-80 years old; Normal neurological examination except for dystonia; Normal brain MRI; The subject or their family members can fully understand the trial and sign the informed consent; Good compliance and willingness to receive regular follow-ups.
Exclusion: Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc); CD with obvious trunk/limb involvement, or Meige syndrome; History of severe mental disorders, dementia, or epilepsy; Accompanied by other neurological diseases (Parkinson's disease, essential tremor, multiple sclerosis, stroke, etc); The patient has or needs other implantable devices (cardiac pacemakers, defibrillators, cochlear implants, spinal cord stimulators, etc); Poor health condition; Diagnosed as secondary CD; Pregnant women or women who are waiting to become pregnant during the trial.