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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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27 November 2023 |
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Main ID: |
NCT03665493 |
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Date of registration:
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04/09/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Dopamine Effect on Inhibitory Control
DEI |
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Scientific title:
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Dopamine Effect on Inhibitory Control |
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Date of first enrolment:
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September 30, 2020 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03665493 |
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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: Factorial Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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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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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Right-handedness (as assessed by the Edinburgh Handedness Inventory)
2. Being in stable treatment with the administration of L-dopa and dopamine agonists
(i.e. not having motor fluctuations and/or dyskinesia)
3. Having a Hoehn & Yahr score between 1.5 and 3
Exclusion Criteria:
1. Presence of severe sensory deficits
2. Presence of overt signs of dementia (a. mini-mental state examination, MMSE must be
=24; b. intelligence quotient =75).
3. Comorbidity with other psychiatric disorders that might interfere with task execution
(i.e. attentional disorders).
4. Presence of severe tremor or rigidity of the right arm in the OFF medication state.
Age minimum:
40 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Idiopathic Parkinson's Disease
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Intervention(s)
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Drug: PD patients H&Y=1.5-2 Medications OFF
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Drug: PD patients H&Y=1.5-2 Medications ON
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Drug: PD patients H&Y=3 Medications OFF
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Drug: PD patients H&Y=3 Medications ON
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Behavioral: Healthy age-matched controls
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Primary Outcome(s)
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Changes of the length of Reaction Times and Movement Times
[Time Frame: Up to one year]
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Changes of length of the Stop Signal Reaction Time
[Time Frame: Up to one year]
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Secondary ID(s)
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GMirab_01
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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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