Efficacy and Safety of DBS in Patients With Primary Dystonia

NCT03017586 | Completed DMC

• 1 other identifier: PINS-023
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (1)

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

  3，6 months

Secondary Outcomes (6)

• Short-Form General Health Survey (SF-36)

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

• Visual analogue scale

  3，6 months

• Measurements of walking

  3，6 months

• The Beck Depression Inventory

  3，6 months

• Mini-Mental State Examination

  3，6 months

Study Arms (2)

STN

EXPERIMENTAL

DBS target with Subthalamic Nucleus (STN).

Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator

GPi

EXPERIMENTAL

DBS target with Globus Pallidus Internus (GPi).

Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator

Interventions

Beijing Pins Medical Co., Ltd. Deep Brain Stimulator DEVICE

Deep Brain Stimulation for primary dystonia subjects

GPi; STN

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beijing Pins Medical Co., Ltd: lead

Study Sites (7)

Beijing Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Tongji Hospital of Tongji Univeristy

Shanghai, Shanghai Municipality, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, China

Location

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

Hangzhou, Zhejiang, China

Location

Related Publications (19)

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• 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.

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• 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.

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• 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.

  PMID: 12378060 BACKGROUND

• 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.

  PMID: 12015845 BACKGROUND

• 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.

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• 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.

  PMID: 7609923 BACKGROUND

• 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.

  PMID: 10938434 BACKGROUND

• 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.

  PMID: 10899228 BACKGROUND

• 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.

  PMID: 14745464 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 14668299 BACKGROUND

• 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.

  PMID: 17093249 BACKGROUND

• Vidailhet M, Vercueil L, Houeto JL, Krystkowiak P, Benabid AL, Cornu P, Lagrange C, Tezenas du Montcel S, Dormont D, Grand S, Blond S, Detante O, Pillon B, Ardouin C, Agid Y, Destee A, Pollak P; French Stimulation du Pallidum Interne dans la Dystonie (SPIDY) Study Group. Bilateral deep-brain stimulation of the globus pallidus in primary generalized dystonia. N Engl J Med. 2005 Feb 3;352(5):459-67. doi: 10.1056/NEJMoa042187.

  PMID: 15689584 BACKGROUND

• Volkmann J, Wolters A, Kupsch A, Muller J, Kuhn AA, Schneider GH, Poewe W, Hering S, Eisner W, Muller JU, Deuschl G, Pinsker MO, Skogseid IM, Roeste GK, Krause M, Tronnier V, Schnitzler A, Voges J, Nikkhah G, Vesper J, Classen J, Naumann M, Benecke R; DBS study group for dystonia. Pallidal deep brain stimulation in patients with primary generalised or segmental dystonia: 5-year follow-up of a randomised trial. Lancet Neurol. 2012 Dec;11(12):1029-38. doi: 10.1016/S1474-4422(12)70257-0. Epub 2012 Nov 1.

  PMID: 23123071 BACKGROUND

• Cao C, Pan Y, Li D, Zhan S, Zhang J, Sun B. Subthalamus deep brain stimulation for primary dystonia patients: a long-term follow-up study. Mov Disord. 2013 Nov;28(13):1877-82. doi: 10.1002/mds.25586. Epub 2013 Jul 16.

  PMID: 23861342 BACKGROUND

• Wang L, Shang H, Jin L, Xiong N, Hu X, Wang W, Liu Y, Yan J, Gao L, Wang Y, Wang Y, Fu P, Cai H, Zhang W, Xu S, Teng F, Ou R, Qiao L, Yang Y, Zhang M, Guo Y, Wan X. Subthalamic deep brain stimulation in isolated generalised or segmental dystonia (RELAX Study): a multicentre, randomised, double-blind, controlled trial. J Neurol Neurosurg Psychiatry. 2025 Oct 15;96(11):1077-1088. doi: 10.1136/jnnp-2025-335829.

  PMID: 40480805 DERIVED

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 11, 2017
• Study Start: December 27, 2017
• Primary Completion: September 13, 2020
• Study Completion: December 17, 2021
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified data may be available after results have been published
• Access Criteria: Individual participant data is available upon request.

Locations

CN (7)