Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
NCT ID: NCT02388204
Last Updated: 2015-03-17
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
20 participants
INTERVENTIONAL
2014-06-30
2017-12-31
Brief Summary
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This study aims to explore the effects of spinal cord stimulation in locomotion, falls and freezing of gait in advanced PD patients.
Twenty PD patients will undergo thoracic spinal cord stimulation at high frequencies in a prospective study for six months.
Changes in locomotion capacity and freezing of gait rating will be the primary out come. Secondary outcomes will be: QoL and common motor outcome measures in PD patients. Always comparing the status before, one, three and six months after stimulation was initiated. A double blind trial will be performed within three months of follow up (high X low frequency stimulation).
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Detailed Description
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Aim: Evaluated Spinal cord stimulation effects in locomotion, gait, freezing and falls in PD patient's.
Method: 20 PD patients will undergo thoracic spinal cord stimulation with high frequency in a prospective study for six months. Gait and freezing evaluation will consists in: timed up and go test, timed up and go test with dual task, 20 m walk test, 20 m walk test with obstacle, freezing of gait scale and falls scale. PDQ 39 and Schwab and England scales will be used to measure quality of life. Unified Parkinson's Disease Rating Scale for motor symptoms and general evaluation. All tests will be done before surgery, after one week, one, three, six months. All patients will be stimulated with the same parameters: High frequencies and 90 mcs pulse width and the sensory threshold will be measured. At the third month the parameters of SCS will be changed and comparative tested for low frequency in a double blind trail.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Parkinson's disease patients
Group description: PD patients with locomotion problems as the primary complain with no interventions other than medication and rehabilitation therapies Intervention: Implantable spinal cord stimulation.
Implantable spinal cord stimulation
Implantation of SCS electrode and pulse generator
DBS Parkinson's disease patients
Group description: PD patients with locomotion problems as the primary complain after cardinal symptoms are controlled by DBS.
Intervention: Implantable spinal cord stimulation.
Implantable spinal cord stimulation
Implantation of SCS electrode and pulse generator
Interventions
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Implantable spinal cord stimulation
Implantation of SCS electrode and pulse generator
Implantable spinal cord stimulation
Implantation of SCS electrode and pulse generator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Gait and locomotion problems as the main complain/symptom
3. PD patients with or without DBS
4. Hoehn and Yahr scale equal or more than 2.0
Exclusion Criteria
2. Hoehn and Yahr scale more than 4
3. Less than 5 years of Parkinson's disease symptoms
4. General contraindications of surgery
45 Years
70 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Erich Talamoni Fonoff
Professor of Neurosurgery
Principal Investigators
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Erich T Fonoff, MD/PhD/Prof
Role: PRINCIPAL_INVESTIGATOR
University of São Paulo, Department of Neurology
Locations
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Division of Functional Neurosurgery
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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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.
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.
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.
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.
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.
Thevathasan W, Mazzone P, Jha A, Djamshidian A, Dileone M, Di Lazzaro V, Brown P. Spinal cord stimulation failed to relieve akinesia or restore locomotion in Parkinson disease. Neurology. 2010 Apr 20;74(16):1325-7. doi: 10.1212/WNL.0b013e3181d9ed58. No abstract available.
Other Identifiers
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USaoPaulo1
Identifier Type: -
Identifier Source: org_study_id
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