A Randomized Controlled Trial Comparing PAllidal and SubThalamic Deep Brain Stimulation for Cervical Dystonia(the PASTS-CD Study)

Status: Not_yet_recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Chinese PLA General Hospital
Beijing
Contact Information
Primary
Zhiqi Mao, PhD
markmaoqi@126.com
8618910155994
Backup
Bin Liu, MD
liubinsdu@163.com
8618561812781
Time Frame
Start Date: 2023-09-01
Completion Date: 2026-11-30
Participants
Target number of participants: 98
Treatments
Experimental: GPi-DBS
The DBS electrodes are implanted into posteroventral GPi bilaterally.
Experimental: STN-DBS
The DBS electrodes are implanted into dorsolateral STN bilaterally.
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov