NCT03665493Completed
Dopamine Effect on Inhibitory Control
Source: ClinicalTrials.gov · Last updated 18 Nov 2023
Brief summary (registry, in English)
The effect of Levodopa medication on inhibitory control in Parkinson's patients is extremely debated despite the fact that this has potential clinical and therapeutic implications. A key confounding factor of many previous studies is that they did not take the disease duration in consideration. In fact, in moderate-to-advanced stages of Parkinson dopaminergic drugs could not produce a clear effect because too few dopaminergic cells for the drugs to operate on survived. Hence, in this study, we will compare the performance in the stop signal task in early-stage versus moderate-to-advanced stages Parkinson's patients both in ON and in OFF medication. In addition, to have a baseline measure of inhibitory control we will compare patient's performances with that of age-matched subjects.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 4 Sept 2018
- Start date
- 30 Sept 2020
- Primary completion date
- 20 Jan 2023
- Lead sponsor
- Giovanni Mirabella
- Diseases
- Parkinson disease
- NCT number
- NCT03665493
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 30 Sept 2020 to the primary completion date, 20 Jan 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of severe tremor or rigidity of the right arm in the OFF medication state.
Other illness
- Presence of overt signs of dementia (a. mini-mental state examination, MMSE must be ≥24; b. intelligence quotient ≥75).
- Comorbidity with other psychiatric disorders that might interfere with task execution (i.e. attentional disorders).
Other
- Presence of severe sensory deficits
Who the study is looking for
- Right-handedness (as assessed by the Edinburgh Handedness Inventory)
- Being in stable treatment with the administration of L-dopa and dopamine agonists (i.e. not having motor fluctuations and/or dyskinesia)
- Having a Hoehn \& Yahr score between 1.5 and 3
Age in the registry: 40 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCSS Neuromed Hospital Coordinator of this site? Confirm its status | Pozzilli | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.