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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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24 August 2015 |
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Main ID: |
NCT02525393 |
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Date of registration:
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11/08/2015 |
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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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Transcranial Stimulation in Motor Stroke Rehabilitation
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Scientific title:
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Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02525393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), 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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Italy
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Contacts
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Name:
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Federico D'Agata, PhD |
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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 Turin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ischemic or hemorrhagic stroke (> 6 months from the accident)
Exclusion Criteria:
- general cognitive impairment (Mini Mental State Examination < 25), severe functional
disability (Barthel Index < 45),
- psychiatric disorders,
- degenerative neurological disorders,
- epilepsy,
- severe medical conditions,
- having been implanted a drug infusion system, spinal/brain-stimulator, or
endovascular coil
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Device: Sham
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Device: tDCS
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Device: rTMS
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Primary Outcome(s)
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Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
[Time Frame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months]
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Secondary Outcome(s)
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P300 (latency)
[Time Frame: Baseline; 1 month; 6 months and 1 week; 7 months]
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Cognition (standardized neuropsychological assessment)
[Time Frame: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months]
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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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