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NCT05715138
Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia
Conditions: Cervical Dystonia
Sex: All
Ages: 18 Years – 80 Years
Phase: NA
Enrollment: 98
Sponsor: Chinese PLA General Hospital
Location: China
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 Criteria
Inclusion Criteria:Diagnosis of idiopathic or hereditary CD;Severe functional impairment despite optimal medical management;No secondary causes of CD;Normal neurological examination except for dystonia;Normal brain MRI;The subject or their family members can fully understand the treatment and sign the informed consent;willing to accept regular follow-up.Exclusion Criteria:Secondary CD;CD with obvious trunk/limb involvement, or Meige syndrome;History of severe mental disorders, dementia, or epilepsy;Previous dystonia surgery (pallidotomy, thalamotomy, or previous DBS);Accompanied by other neurological diseases (Parkinson's disease, essential tremor, stroke);The patient has or needs other implantable devices (cardiac pacemakers, defibrillators, cochlear implants, or spinal cord stimulators);Demand of 3-Tesla MRI examination during the future clinical trial;Poor health condition.
Source: ClinicalTrials.gov (NCT05715138). StuddyBuddy aggregates publicly available trial information.