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Search / Trial NCT05715138

Comparison of Pallidal With Subthalamic Deep Brain Stimulation for Cervical Dystonia

Launched by CHINESE PLA GENERAL HOSPITAL · Jan 29, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Globus Pallidus Internus Subthalamic Nucleus Deep Brain Stimulation

ClinConnect Summary

This clinical trial is looking to compare two types of deep brain stimulation (DBS) treatments for a condition called cervical dystonia, which causes involuntary twisting or tilting of the head. The researchers want to find out whether targeting a specific area in the brain called the subthalamic nucleus (STN) is more effective than targeting another area called the globus pallidus internus (GPi). By studying how these treatments affect symptoms, quality of life, and potential side effects, they hope to understand which method works better, especially in the long run.

To be eligible for the trial, participants need to be between 18 and 80 years old, have been diagnosed with cervical dystonia that hasn’t improved with medication or botulinum toxin injections, and generally be in good health aside from their condition. They should also have a normal brain scan and be willing to follow up regularly. If you or a loved one meets these criteria, you could play an important role in helping researchers find the best treatment for cervical dystonia.

Gender

ALL

Eligibility criteria

  • Inclusion criteria
  • 1. Diagnosed as idiopathic or hereditary isolated CD;
  • 2. Severe functional impairment;
  • 3. Oral medication and injection of botulinum toxin become ineffective (\> 3 months since last injection), or refuse to adopt botulinum toxin injection;
  • 4. No secondary causes of CD;
  • 5. Age 18-80 years old;
  • 6. Normal neurological examination except for dystonia;
  • 7. Normal brain MRI;
  • 8. The subject or their family members can fully understand the trial and sign the informed consent;
  • 9. Good compliance and willingness to receive regular follow-ups.
  • Exclusion criteria
  • 1. Diagnosed as secondary CD;
  • 2. CD with obvious trunk/limb involvement, or Meige syndrome;
  • 3. History of severe mental disorders, dementia, or epilepsy;
  • 4. Previous dystonia surgery (pallidotomy, thalamotomy, DBS, etc);
  • 5. Accompanied by other neurological diseases (Parkinson's disease, essential tremor, multiple sclerosis, stroke, etc);
  • 6. The patient has or needs other implantable devices (cardiac pacemakers, defibrillators, cochlear implants, spinal cord stimulators, etc);
  • 7. Pregnant women or women who are waiting to become pregnant during the trial;
  • 8. Poor health condition.

About Chinese Pla General Hospital

The Chinese PLA General Hospital, a prominent military medical institution in Beijing, serves as a leading sponsor for clinical trials, focusing on advancing healthcare through innovative research and development. Renowned for its comprehensive medical services and cutting-edge research capabilities, the hospital is committed to improving patient outcomes through rigorous scientific investigation and collaboration with various stakeholders in the healthcare sector. With a multidisciplinary approach and a strong emphasis on evidence-based practices, the Chinese PLA General Hospital aims to contribute significantly to the global medical community by facilitating the development of safe and effective therapeutic interventions.

Locations

Beijing, , China

Patients applied

0 patients applied

Trial Officials

Zhiqi Mao, PhD

Principal Investigator

Chinese PLA General Hospital

Bin Liu, MD

Principal Investigator

Chinese PLA General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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