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Clinical Trial of STN-DBS for Primary Cranial-Cervical Dystonia

NCT02583074 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-20

No results posted yet for this study

Summary

Primary cranial-cervical dystonia is managed mainly by repeated botulinum toxin injections.This study is to establish whether subthalamic nucleus neurostimulation could improve symptoms in patients not adequately responding to chemodenervation or oral drug treatment. Investigators compared this surgical treatment with sham stimulation in a randomized, controlled clinical trial.

Conditions

  • Dystonia

Interventions

PROCEDURE

Stimulation

After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.

PROCEDURE

Sham-stimulation

After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER

  • China-Japan Friendship Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Zhang Jian-guo, MD · Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583074 on ClinicalTrials.gov