We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 237 for:    "dopa-responsive dystonia" OR "Dystonia"

A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02263417
Recruitment Status : Recruiting
First Posted : October 13, 2014
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Brief Summary:
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

Condition or disease Intervention/treatment Phase
Dystonia Device: Deep Brain Stimulation (DBS) of Gpi Device: Deep Brain Stimulation (DBS) of STN Early Phase 1

Detailed Description:
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Deep Brain Stimulation
Stimulation is on
Device: Deep Brain Stimulation (DBS) of Gpi
Other Name: Rechargeable Neurostimulator
Device: Deep Brain Stimulation (DBS) of STN
Other Name: Rechargeable Neurostimulator
Sham Comparator: Placebo
Stimulation is off
Device: Deep Brain Stimulation (DBS) of Gpi
Other Name: Rechargeable Neurostimulator
Device: Deep Brain Stimulation (DBS) of STN
Other Name: Rechargeable Neurostimulator



Primary Outcome Measures :
  1. Burke-Fahn-Marsden Scale (BFM) [ Time Frame: Change from baseline in BMF at 1, 3 months and 6 months ]

Secondary Outcome Measures :
  1. Quality of life (SF-36) [ Time Frame: Change from baseline in SF-36 at 1, 3 months and 6 months ]
  2. Psychiatric assessment (HADS-D and PANSS) [ Time Frame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is aged 18 to 75 years old, male or female.
  2. Diagnosed with cervical dystonia by a movement disorders neurologist.
  3. Has cervical dystonia alone, not generalized or multifocal.
  4. Has had adequate trials of medical therapy.

Exclusion Criteria:

  1. Cognitive impairment.
  2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
  3. Medical conditions precluding general anaesthetic or surgery.
  4. Unstable psychiatric disease.
  5. Previous brain lesions to treat cervical dystonia.
  6. Attended some other trials within three month.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263417


Contacts
Contact: Jia Fumin, PhD +86 010-59361265 pins_medical@163.com

Locations
China, Beijing
Peking union medical college hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Yi Guo         
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Peking Union Medical College Hospital
Investigators
Study Chair: Li Luming, PhD Tsinghua University

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02263417     History of Changes
Other Study ID Numbers: PINS-005
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases