Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
15 participants
INTERVENTIONAL
2016-02-29
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Spinal cord stimulation
Boston Scientific SCS system
Spinal cord stimulation
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
Interventions
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Spinal cord stimulation
Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Idiopathic PD with II-IV Hoehn-Yahn stage
* A history of frequent falls, gait and balance dysfunction and postural instability
* ON-freezing
* Ability to perform a gait/walking task (under close supervision),
* PD participants referred by Dr. Jog to the functional neurosurgeon for SCS implantation for treatment of their gait and balance dysfunction and/or for their freezing of gait.
* SCS eligibility has been confirmed by neurologist and neurosurgeon
* Patients who receive SCS for their gait and mobility must participate in this study in order to determine which SCS parameters provide the patient with the best outcome for their PD symptoms.
* able to give informed consent
* Able to attend all clinic visits and assessments
* No dementia or psychiatric abnormalities on neuropsychological testing
* No significant secondary causes (such as cerebrovascular disease, normal pressure hydrocephalus, peripheral neuropathy, severe degenerative lower limb or back disease).
* we had a few devices to include exploratory trial in atypical PD (MSA, PSP, and CBD confirmed diagnosis from clinic).
Exclusion Criteria
* History of ALS or Myasthenia Gravis
* Offending medications (Lithium, valproate, steroids, amiodarone, beta-adrenergic agonists (e.g. salbutamol).
* Persons prescribed zonisamide
* Women reporting that they are pregnant
* Persons medically unstable with contraindications to SCS will be excluded
* Previous brain surgery or cardiac pacemaker
* Eligibility for deep brain stimulation surgery
* Moderately severe parkinsonism in the context of unstable pharmacological treatment
* Dementia as assessed by DSM criteria or severe cognitive disturbances
* Severe psychiatric symptoms (in particular, hallucinations and depression)
* Bad general health
* Lack of compliance at follow-up
* Severe dyskinesias
* Significant cognitive impairment
18 Years
80 Years
ALL
No
Sponsors
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Western University, Canada
OTHER
Responsible Party
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Principal Investigators
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Mandar Jog, MD
Role: PRINCIPAL_INVESTIGATOR
LHSC
Locations
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London Health Sciences Centre
London, Ontario, Canada
Countries
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Central Contacts
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Mandar Jog, MD
Role: CONTACT
Olivia Samotus, MSc
Role: CONTACT
Facility Contacts
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References
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Fuentes R, Petersson P, Nicolelis MA. Restoration of locomotive function in Parkinson's disease by spinal cord stimulation: mechanistic approach. Eur J Neurosci. 2010 Oct;32(7):1100-8. doi: 10.1111/j.1460-9568.2010.07417.x.
Santana MB, Halje P, Simplicio H, Richter U, Freire MAM, Petersson P, Fuentes R, Nicolelis MAL. Spinal cord stimulation alleviates motor deficits in a primate model of Parkinson disease. Neuron. 2014 Nov 19;84(4):716-722. doi: 10.1016/j.neuron.2014.08.061. Epub 2014 Oct 30.
Jenkinson N, Nandi D, Muthusamy K, Ray NJ, Gregory R, Stein JF, Aziz TZ. Anatomy, physiology, and pathophysiology of the pedunculopontine nucleus. Mov Disord. 2009 Feb 15;24(3):319-28. doi: 10.1002/mds.22189.
Nagatsua T, Sawadab M. L-dopa therapy for Parkinson's disease: past, present, and future. Parkinsonism Relat Disord. 2009 Jan;15 Suppl 1:S3-8. doi: 10.1016/S1353-8020(09)70004-5.
Liu HG, Zhang K, Yang AC, Zhang JG. Deep brain stimulation of the subthalamic and pedunculopontine nucleus in a patient with Parkinson's disease. J Korean Neurosurg Soc. 2015 Apr;57(4):303-6. doi: 10.3340/jkns.2015.57.4.303. Epub 2015 Apr 24.
Stefani A, Lozano AM, Peppe A, Stanzione P, Galati S, Tropepi D, Pierantozzi M, Brusa L, Scarnati E, Mazzone P. Bilateral deep brain stimulation of the pedunculopontine and subthalamic nuclei in severe Parkinson's disease. Brain. 2007 Jun;130(Pt 6):1596-607. doi: 10.1093/brain/awl346. Epub 2007 Jan 24.
Ferraye MU, Debu B, Fraix V, Goetz L, Ardouin C, Yelnik J, Henry-Lagrange C, Seigneuret E, Piallat B, Krack P, Le Bas JF, Benabid AL, Chabardes S, Pollak P. Effects of pedunculopontine nucleus area stimulation on gait disorders in Parkinson's disease. Brain. 2010 Jan;133(Pt 1):205-14. doi: 10.1093/brain/awp229. Epub 2009 Sep 22.
Giladi N, Horak FB, Hausdorff JM. Classification of gait disturbances: distinguishing between continuous and episodic changes. Mov Disord. 2013 Sep 15;28(11):1469-73. doi: 10.1002/mds.25672.
Fuentes R, Petersson P, Siesser WB, Caron MG, Nicolelis MA. Spinal cord stimulation restores locomotion in animal models of Parkinson's disease. Science. 2009 Mar 20;323(5921):1578-82. doi: 10.1126/science.1164901.
Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.
Hassan S, Amer S, Alwaki A, Elborno A. A patient with Parkinson's disease benefits from spinal cord stimulation. J Clin Neurosci. 2013 Aug;20(8):1155-6. doi: 10.1016/j.jocn.2012.08.018. Epub 2013 Feb 26.
Agari T, Date I. Spinal cord stimulation for the treatment of abnormal posture and gait disorder in patients with Parkinson's disease. Neurol Med Chir (Tokyo). 2012;52(7):470-4. doi: 10.2176/nmc.52.470.
Landi A, Trezza A, Pirillo D, Vimercati A, Antonini A, Sganzerla EP. Spinal cord stimulation for the treatment of sensory symptoms in advanced Parkinson's disease. Neuromodulation. 2013 May-Jun;16(3):276-9. doi: 10.1111/ner.12005. Epub 2012 Dec 10. No abstract available.
Yadav AP, Fuentes R, Zhang H, Vinholo T, Wang CH, Freire MA, Nicolelis MA. Chronic spinal cord electrical stimulation protects against 6-hydroxydopamine lesions. Sci Rep. 2014 Jan 23;4:3839. doi: 10.1038/srep03839.
Other Identifiers
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107451
Identifier Type: -
Identifier Source: org_study_id
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