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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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16 December 2017 |
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Main ID: |
NCT03076307 |
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Date of registration:
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06/03/2017 |
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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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DAT SPECT and Procedural Motor Skills in Parkinson's Disease
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Scientific title:
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Correlation of Procedural Motor Skills Impairment and 123I-FP-CIT SPECT Uptake in Patients With Early Parkinson's Disease: a Case-control Study |
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Date of first enrolment:
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October 18, 2016 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03076307 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science.
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Phase:
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N/A
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Countries of recruitment
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France
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Switzerland
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Key inclusion & exclusion criteria
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Inclusion criteria for PD group:
- Age > 18 year-old
- Diagnosis of PD with onset <2 years from enrollment
- Available DAT SPECT performed in Geneva University Hospitals <6 months before
inclusion
Inclusion criteria for control group:
Age- and sex-matched control patients
- Age > 18 year-old
- No known neurological condition interfering with motor and cognitive abilities
- No medication interfering with central nervous system (including antidepressants,
antipsychotics, hypnotics)
Exclusion criteria for both groups:
- Major depressive state (Hospital Anxiety and Depression scale =11 for depression
score)
- Cognitive decline (Mini-Mental Score = 22/30)
- Debilitating tremor (Movement Disorders Society - Unified Parkinson's Disease Rating
Scale (MDS-UPDRS) part III - rest, postural and action tremor =2/4)
- Significant akinesia (MDS-UPDRS III hand brady-akinesia score =2/4)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Behavioral: Procedural Motor Skills with mirror-drawing of figures
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Primary Outcome(s)
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Procedural motor performance (error and time) in PD group
[Time Frame: 2 days]
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Secondary Outcome(s)
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Resting state EEG connectivity in PD and control groups
[Time Frame: 2 days]
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Difference >20% in error rate and speed improvement in control and PD groups
[Time Frame: 2 days]
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Secondary ID(s)
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CCER 2016-01469
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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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