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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 March 2015 |
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Main ID: |
NCT02388204 |
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Date of registration:
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08/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease
SCSPD |
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Scientific title:
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Spinal Cord Stimulation for the Treatment of Motor and Nonmotor Symptoms of Parkinson's Disease |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02388204 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Erich T Fonoff, MD/PhD/Prof |
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Address:
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Telephone:
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5511983268848/551126616402 |
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Email:
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fonoffet@usp.br |
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Affiliation:
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Name:
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Erich T Fonoff, MD/PhD/Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of São Paulo, Department of Neurology |
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Name:
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Erich T Fonoff, MD/PhD/Prof |
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Address:
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Telephone:
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5511983238848 |
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Email:
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fonoffet@usp.br |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Idiopathic PD
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:
1. Dementia
2. Hoehn and Yahr scale more than 4
3. Less than 5 years of Parkinson's disease symptoms
4. General contraindications of surgery
Age minimum:
45 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Procedure: Implantable spinal cord stimulation
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Primary Outcome(s)
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Changes in locomotion capacity
[Time Frame: 6 months]
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Secondary Outcome(s)
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Changes in freezing of Gait
[Time Frame: 6 months]
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Changes in quality of life
[Time Frame: 6 months]
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Motor changes
[Time Frame: 6 months]
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Secondary ID(s)
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USaoPaulo1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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