Efficacy and Safety of DBS in Patients With Primary 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. Identifier: NCT03017586
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for primary dystonia.

Condition or disease Intervention/treatment
Dystonia Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator

Detailed Description:
Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS), Changes in cognitive function will be assessed with neuropsychological testing. Stimulation parameters will be documented, and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects. Patient weight will be recorded at study visits. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) in Patients With Primary Dystonia(RELAX Study)
Actual Study Start Date : December 27, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: STN
DBS target with Subthalamic Nucleus (STN).
Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Deep Brain Stimulation for primary dystonia subjects
Experimental: GPi
DBS target with Globus Pallidus Internus (GPi).
Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Deep Brain Stimulation for primary dystonia subjects

Primary Outcome Measures :
  1. change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score [ Time Frame: 3,6 months ]

Secondary Outcome Measures :
  1. Short-Form General Health Survey (SF-36) [ Time Frame: 3,6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety) ]
    Quality of life was assessed with the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), which evaluates both physical and mental components of functioning on a scale of 0 to 100, with higher scores indicating a higher level of function.

  2. Visual analogue scale [ Time Frame: 3,6 months ]
    The severity of dystonia and pain was assessed with the use of a visual analogue scale, with scores ranging from 0 to 10 and higher scores indicating greater severity

  3. Measurements of walking [ Time Frame: 3,6 months ]
    Measurements of walking (the duration and number of steps taken in a 14-m walk with one turn)

  4. The Beck Depression Inventory [ Time Frame: 3,6 months ]
    The Beck Depression Inventory (with scores ranging from 0 to 63 and higher scores indicating more severe depression)

  5. MMSE [ Time Frame: 3,6 months ]
    Cognitive were assessed by mini-mental state examination

  6. The rate of improvement of BFMDRS score [ Time Frame: 3,6 months ]
    The rate of improvement of BFMDRS score that >25%、>50%、>75%

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Ages Eligible for Study:   6 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Refractory primary (systemic, segmental) dystonia diagnosed by a movement disorders neurologist
  2. Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
  3. Ability to follow up with post-operative study visits
  4. Patients and their relatives have reasonable surgery expectations
  5. Volunteer to participate in clinical trials, and signed consent form
  6. Age 6-60 years

Exclusion Criteria:

  1. Pregnancy or plan a pregnancy
  2. Good treatment with Non-invasive therapy
  3. Dopamine reactive dystonia ,Genetic degeneration ,Paroxysmal dystonia ,Secondary dystonia, Psychogenic dystonia
  4. Brain MRI showing extensive brain atrophy or small vessel ischemic disease
  5. Cognitive impairment(MMSE<24)
  6. Severe depression or other serious mental illness
  7. History of traumatic brain injury, tumor, or severe cerebrovascular disease
  8. Severe brain atrophy (diagnosed by CT or MRI)
  9. Hyperthermia therapy in implant parts
  10. Abnormal in blood inspection, blood clotting disorders, liver and kidney dysfunction, or other clinical judgment cannot tolerate surgery
  11. High blood pressure, serious heart diseases, or respiratory diseases
  12. Diabetes
  13. Long-term treatment of immunosuppressive or hormones
  14. Implant pacemakers, defibrillators, cochlear and other nerve stimulators
  15. Other diseases need frequent MRI examinations
  16. Participated in any other clinical trials within 3 months
  17. Reluctant or unable to implant surgery
  18. Reluctant or unable to cooperate with follow-up
  19. Other exclusion Criteria by researchers

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 identifier (NCT number): NCT03017586

Contact: Fumin Jia, Ph.D +86 010-60736388 pins_medical@163.con
Contact: Luming Li, Dr. +86 010-60736388

China, Beijing
Beijing XieHe Hospital Recruiting
Beijing, Beijing, China
Contact: XinHua Wan, Dr.         
China, Zhejiang
Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Xingyue Hu, MD         
Sponsors and Collaborators
Beijing Pins Medical Co., Ltd

Responsible Party: Beijing Pins Medical Co., Ltd Identifier: NCT03017586     History of Changes
Other Study ID Numbers: PINS-023
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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