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DystoniaNCT03017586

Efficacy and Safety of DBS in Patients With Primary Dystonia

A study testing Beijing Pins Medical Co., Ltd. Deep Brain Stimulator in people with Dystonia, run by Beijing Pins Medical Co., Ltd at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 60 years
Conditions the study is for
Dystonia
What is being tested?
Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
7 sitesChina
Study dates
27 Dec 2017to 17 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Beijing Union Medical College Hospital

    Beijing, Beijing Municipality

  • West China Hospital Sichuan University

    Chengdu, Sichuan

  • Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University

    Hangzhou, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Nanjing Brain Hospital

    Nanjing, Jiangsu

  • Tongji Hospital of Tongji Univeristy

    Shanghai, Shanghai Municipality

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

Official title: Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) in Patients With Primary Dystonia（RELAX Study）

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.

Read the 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.

Conditions
Dystonia
Being tested
Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Medical subject headings
Dystonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beijing Pins Medical Co., Ltd. Deep Brain StimulatorDevice

    Deep Brain Stimulation for primary dystonia subjects

Study groups in NCT03017586
Study groupRoleWhat they receive
STNExperimentalDBS target with Subthalamic Nucleus (STN).
Receives: Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
GPiExperimentalDBS target with Globus Pallidus Internus (GPi).
Receives: Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score

    Measured: 3，6 months

Secondary outcomes (6)

  1. Short-Form General Health Survey (SF-36)

    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.

    Measured: 3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety)

  2. Visual analogue scale

    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

    Measured: 3，6 months

  3. Measurements of walking

    Measurements of walking (the duration and number of steps taken in a 14-m walk with one turn)

    Measured: 3，6 months

  4. The Beck Depression Inventory

    The Beck Depression Inventory (with scores ranging from 0 to 63 and higher scores indicating more severe depression)

    Measured: 3，6 months

  5. Mini-Mental State Examination

    Cognitive were assessed by mini-mental state examination

    Measured: 3，6 months

  6. The rate of improvement of BFMDRS score

    The rate of improvement of BFMDRS score that >25%、>50%、>75%

    Measured: 3，6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start27 Dec 2017
  3. Primary completion13 Sep 2020
  4. Study completion17 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017586
Sponsor's protocol ID
PINS-023
Status last verified
Aug 2024
First submitted
5 Jan 2017
Last updated
7 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data is available upon request.

Publications

  • Benabid AL, Pollak P, Louveau A, Henry S, de Rougemont J. Combined (thalamotomy and stimulation) stereotactic surgery of the VIM thalamic nucleus for bilateral Parkinson disease. Appl Neurophysiol. 1987;50(1-6):344-6. doi: 10.1159/000100803.

    PubMed 3329873

  • Deep-Brain Stimulation for Parkinson's Disease Study Group; Obeso JA, Olanow CW, Rodriguez-Oroz MC, Krack P, Kumar R, Lang AE. Deep-brain stimulation of the subthalamic nucleus or the pars interna of the globus pallidus in Parkinson's disease. N Engl J Med. 2001 Sep 27;345(13):956-63. doi: 10.1056/NEJMoa000827.

    PubMed 11575287

  • Krack P, Pollak P, Limousin P, Hoffmann D, Xie J, Benazzouz A, Benabid AL. Subthalamic nucleus or internal pallidal stimulation in young onset Parkinson's disease. Brain. 1998 Mar;121 ( Pt 3):451-7. doi: 10.1093/brain/121.3.451.

    PubMed 9549521

  • Herzog J, Volkmann J, Krack P, Kopper F, Potter M, Lorenz D, Steinbach M, Klebe S, Hamel W, Schrader B, Weinert D, Muller D, Mehdorn HM, Deuschl G. Two-year follow-up of subthalamic deep brain stimulation in Parkinson's disease. Mov Disord. 2003 Nov;18(11):1332-7. doi: 10.1002/mds.10518.

    PubMed 14639676

  • Beric A, Kelly PJ, Rezai A, Sterio D, Mogilner A, Zonenshayn M, Kopell B. Complications of deep brain stimulation surgery. Stereotact Funct Neurosurg. 2001;77(1-4):73-8. doi: 10.1159/000064600.

    PubMed 12378060

  • Oh MY, Abosch A, Kim SH, Lang AE, Lozano AM. Long-term hardware-related complications of deep brain stimulation. Neurosurgery. 2002 Jun;50(6):1268-74; discussion 1274-6. doi: 10.1097/00006123-200206000-00017.

    PubMed 12015845

  • Umemura A, Jaggi JL, Hurtig HI, Siderowf AD, Colcher A, Stern MB, Baltuch GH. Deep brain stimulation for movement disorders: morbidity and mortality in 109 patients. J Neurosurg. 2003 Apr;98(4):779-84. doi: 10.3171/jns.2003.98.4.0779.

    PubMed 12691402

  • Benazzouz A, Piallat B, Pollak P, Benabid AL. Responses of substantia nigra pars reticulata and globus pallidus complex to high frequency stimulation of the subthalamic nucleus in rats: electrophysiological data. Neurosci Lett. 1995 Apr 14;189(2):77-80. doi: 10.1016/0304-3940(95)11455-6.

    PubMed 7609923

  • Benazzouz A, Gao DM, Ni ZG, Piallat B, Bouali-Benazzouz R, Benabid AL. Effect of high-frequency stimulation of the subthalamic nucleus on the neuronal activities of the substantia nigra pars reticulata and ventrolateral nucleus of the thalamus in the rat. Neuroscience. 2000;99(2):289-95. doi: 10.1016/s0306-4522(00)00199-8.

    PubMed 10938434

  • Dostrovsky JO, Levy R, Wu JP, Hutchison WD, Tasker RR, Lozano AM. Microstimulation-induced inhibition of neuronal firing in human globus pallidus. J Neurophysiol. 2000 Jul;84(1):570-4. doi: 10.1152/jn.2000.84.1.570.

    PubMed 10899228

  • Filali M, Hutchison WD, Palter VN, Lozano AM, Dostrovsky JO. Stimulation-induced inhibition of neuronal firing in human subthalamic nucleus. Exp Brain Res. 2004 Jun;156(3):274-81. doi: 10.1007/s00221-003-1784-y. Epub 2004 Jan 24.

    PubMed 14745464

  • Tai CH, Boraud T, Bezard E, Bioulac B, Gross C, Benazzouz A. Electrophysiological and metabolic evidence that high-frequency stimulation of the subthalamic nucleus bridles neuronal activity in the subthalamic nucleus and the substantia nigra reticulata. FASEB J. 2003 Oct;17(13):1820-30. doi: 10.1096/fj.03-0163com.

    PubMed 14519661

  • Hashimoto T, Elder CM, Okun MS, Patrick SK, Vitek JL. Stimulation of the subthalamic nucleus changes the firing pattern of pallidal neurons. J Neurosci. 2003 Mar 1;23(5):1916-23. doi: 10.1523/JNEUROSCI.23-05-01916.2003.

    PubMed 12629196

  • McIntyre CC, Grill WM, Sherman DL, Thakor NV. Cellular effects of deep brain stimulation: model-based analysis of activation and inhibition. J Neurophysiol. 2004 Apr;91(4):1457-69. doi: 10.1152/jn.00989.2003. Epub 2003 Dec 10.

    PubMed 14668299

  • Kupsch A, Benecke R, Muller J, Trottenberg T, Schneider GH, Poewe W, Eisner W, Wolters A, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Vollmer-Haase J, Brentrup A, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Naumann M, Volkmann J; Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. 2006 Nov 9;355(19):1978-90. doi: 10.1056/NEJMoa063618.

    PubMed 17093249

Questions about this trial

What is this clinical trial studying?

A study testing Beijing Pins Medical Co., Ltd. Deep Brain Stimulator in people with Dystonia, run by Beijing Pins Medical Co., Ltd at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score (time frame: 3，6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017586, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.

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