Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese PLA General Hospital

About this trial

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

Qualifiers

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;

Disqualifiers

Diagnosed as secondary CD;

CD with obvious trunk/limb involvement, or Meige syndrome;

History of severe mental disorders, dementia, or epilepsy;

Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc);

Trial design

Treatments tested in this trial

  • GPi-DBS
  • STN-DBS
  • GPi-DBS devices
  • STN-DBS devices

Treatment groups

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators