Visual Attention in Parkinson's DiseaseVSA-PDNCT01135407
Visual Selective Attention in Parkinson's Disease
An observational study of Visual Attention in Parkinson's Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known to be accompanied in many instances by a variety of cognitive defects. This can be explained considering that PD is a neurodegenerative and progressive disorder of the basal ganglia system, which works modulating not only… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Attention in Parkinson's Disease
- What is being tested?
- Recording during computerized tests
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parkinson's disease patients will be selected among those regularly treated in the Centres that take part to the study. Healthy controls will be selected among patient family circle, and the staff of the Centres where the research takes place.
Who may be able to join
- Idiopathic Parkinson's Disease at a disease's stage characterized by motor complications
- Able to tolerate a prolonged condition without medication
- Levodopa response > 30% (for group #1)
- Self-declared normal or corrected to normal vision
- At least one contact lead in the sensorimotor part and another contact in the associativelimbic part of the STN (for group #2).
- Patients with a healthy social security affiliation
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- Able to give and sign the informed consent
- Self-declared neurologically healthy subjects,
- Self-declared normal or corrected to normal vision
- No psychotropic or neurotrophic drugs intake
- Subjects with a healthy social security affiliation
- Able to give and sign the informed consent
Who cannot join
- Patients under guardianship, interdicted, or under administrative measures and legal constraints
- Fertile women not using adequate contraceptive methods
- Women who are pregnant or breast feeding
- Severe cognitive impairment
- Severe frontal executive functions impairment
- Actual psychotic disorders
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- Major depression
- Motivation impairment
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol
- Significant deficiency in red-green color discrimination
- Drug or alcohol addiction
- Healthy controls: group #3
- Patients under guardianship, interdicted, or under administrative measures and legal constraints
- Fertile women not using adequate contraceptive methods
- Women who are pregnant or breast feeding
- Severe cognitive impairment
- Severe frontal executive functions impairment
- Actual psychotic disorders
- Major depression
- Motivation impairment
- Any medical or psychological problems which may interfere with a smooth conduction of the study protocol
- Significant deficiency in red-green color discrimination
- Drug or alcohol addiction
Trial locations and contacts
1 site in 1 country.
France1 site
Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital
Grenoble, 38043
About this study
Official title: Role of the Cortico-basal Ganglia Loops in Visual Attention: Effects of Dopaminergic and Subthalamic Nucleus Stimulation in Parkinson's Disease
Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known to be accompanied in many instances by a variety of cognitive defects. This can be explained considering that PD is a neurodegenerative and progressive disorder of the basal ganglia system, which works modulating not only motor, but also cognitive and emotional behaviours.
Concerning this, some studies suggest that non-demented PD patients may suffer from a voluntary selective visual attention orienting deficit, showing a reduced skill in focusing upon one target, and may be easily distracted from irrelevant but salient stimuli, with a consequent negative impact on their physical health, social interactions and quality of life.
Read more
Up to now, the evidence of the role of the basal-ganglia system in modulating visual attention functions is poor and indirect and the effects of dopaminergic and subthalamic nucleus (STN) stimulation (two usual and effective treatments in PD) on attention performances are controversial.
The main objectives of the project are: 1) to assess the visual selective attention as well as the distractibility in PD patients; 2) to study the effects of patient's usual antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention performances.
Secondly, from a clinical and neurophysiologic point of view, the investigators want to study the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic cortico-basal ganglia loops passing across the STN in the visual attention performances.
To precisely answer the objectives of the protocol, the investigators will record the performances of participants during the administration of 3 computerized tests, which are suitable to study visual attention, decision making and motor performances.
The investigators will compare the performances on the computerized tests of two groups of PD patients, one evaluated in different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other in different conditions of medication (with or without dopaminergic treatment) with those of a group of healthy subjects.
Read the detailed description
Study Model: parallel-groups study. Three groups of subjects will be enrolled for the study: 2 groups of PD patients (see for details the section groups/cohorts), and a group of healthy controls.
- Conditions
- Visual Attention in Parkinson's Disease
- Being tested
- Recording during computerized tests
- Keywords
- Parkinson's disease, Deep brain stimulation, Subthalamic nucleus, Levodopa, Selective visual attention, Basal ganglia diseases
- Medical subject headings
- Parkinson Disease, Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording during computerized testsOther
Patients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals.
The computerized tests are administered in two different conditions of medication: with or without dopaminergic treatment, corresponding to two different experimental sessions.
Recording during computerized testsOther
Patients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals. The computerized tests are administered in three different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the subthalamic nucleus) stimulation, corresponding to three different experimental sessions.
Recording during computerized testsOther
Participants will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals.The computerized tests are administered twice (in two different experimental sessions) to verify the performance repeatability.
| Study group | Role | What they receive |
|---|---|---|
| group #1 | Parkinson's disease patients at a disease's stage characterized by motor complications Receives: Other: Recording during computerized tests | |
| group #2 | Parkinson's disease patients treated by subthalamic nucleus deep brain stimulation. Receives: Other: Recording during computerized tests | |
| group #3 | healthy controls Receives: Other: Recording during computerized tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaction time in trials of the computerized tests
Reaction times is recorded during one hour sessions for each patient/control subject (for more details see the Intervention Section)
Measured: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week
Secondary outcomes (1)
responses accuracy in trials of the computerized tests
responses accuracy is recorded during one hour sessions for each patient/control subject (for more details see the Intervention Section)
Measured: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Attention in Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Pierre POLLAK, Professor, Principal investigator, Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135407
- Sponsor's protocol ID
- 0914
- Acronym
- VSA-PD
- Status last verified
- Jun 2010
- First submitted
- 1 Jun 2010
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Cortico-basal Ganglia Loops in Visual Attention: Effects of Dopaminergic and Subthalamic Nucleus Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01135407
- Acronym / sponsor ID
- VSA-PD / 0914
- Conditions
- Visual Attention in Parkinson's Disease
- Keywords
- Parkinson's disease, Deep brain stimulation, Subthalamic nucleus, Levodopa, Selective visual attention, Basal ganglia diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease (PD), which is generally considered to be a motor disorder, is now known to be accompanied in many instances by a variety of cognitive defects. This can be explained considering that PD is a neurodegenerative and progressive disorder of the basal ganglia system, which works modulating not only motor, but also cognitive and emotional behaviours.
Concerning this, some studies suggest that non-demented PD patients may suffer from a voluntary selective visual attention orienting deficit, showing a reduced skill in focusing upon one target, and may be easily distracted from irrelevant but salient stimuli, with a consequent negative impact on their physical health, social interactions and quality of life.
Up to now, the evidence of the role of the basal-ganglia system in modulating visual attention functions is poor and indirect and the effects of dopaminergic and subthalamic nucleus (STN) stimulation (two usual and effective treatments in PD) on attention performances are controversial.
The main objectives of the project are: 1) to assess the visual selective attention as well as the distractibility in PD patients; 2) to study the effects of patient's usual antiparkinsonian treatments, that is dopaminergic and STN stimulation, on visual attention performances.
Secondly, from a clinical and neurophysiologic point of view, the investigators want to study the respective role of the dopaminergic pathways and the sensorimotor and associative/limbic cortico-basal ganglia loops passing across the STN in the visual attention performances.
To precisely answer the objectives of the protocol, the investigators will record the performances of participants during the administration of 3 computerized tests, which are suitable to study visual attention, decision making and motor performances.
The investigators will compare the performances on the computerized tests of two groups of PD patients, one evaluated in different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the STN) stimulation, the other in different conditions of medication (with or without dopaminergic treatment) with those of a group of healthy subjects.
Detailed description
Study Model: parallel-groups study. Three groups of subjects will be enrolled for the study: 2 groups of PD patients (see for details the section groups/cohorts), and a group of healthy controls.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group #1 | – | Other: Recording during computerized testsParkinson's disease patients at a disease's stage characterized by motor complications |
| group #2 | – | Other: Recording during computerized testsParkinson's disease patients treated by subthalamic nucleus deep brain stimulation. |
| group #3 | – | Other: Recording during computerized testshealthy controls |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients will be selected among those regularly treated in the Centres that take part to the study. Healthy controls will be selected among patient family circle, and the staff of the Centres where the research takes place.
Key inclusion criteria (12 listed)
- Idiopathic Parkinson's Disease at a disease's stage characterized by motor complications
- Able to tolerate a prolonged condition without medication
- Levodopa response > 30% (for group #1)
- Self-declared normal or corrected to normal vision
- At least one contact lead in the sensorimotor part and another contact in the associativelimbic part of the STN (for group #2).
Key exclusion criteria (23 listed)
- Patients under guardianship, interdicted, or under administrative measures and legal constraints
- Fertile women not using adequate contraceptive methods
- Women who are pregnant or breast feeding
- Severe cognitive impairment
- Severe frontal executive functions impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording during computerized testsPatients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals. The computerized tests are administered in two different conditions of medication: with or without dopaminergic treatment, corresponding to two different experimental sessions. | Other | group #1 |
| Recording during computerized testsPatients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals. The computerized tests are administered in three different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the subthalamic nucleus) stimulation, corresponding to three different experimental sessions. | Other | group #2 |
| Recording during computerized testsParticipants will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals.The computerized tests are administered twice (in two different experimental sessions) to verify the performance repeatability. | Other | group #3 |
Primary outcome
reaction time in trials of the computerized tests
Time frame: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week
Reaction times is recorded during one hour sessions for each patient/control subject (for more details see the Intervention Section)
1 secondary outcome
responses accuracy in trials of the computerized tests
Time frame: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre POLLAK, Professor principal investigator
Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Attention in Parkinson's Disease, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaction time in trials of the computerized tests (time frame: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2010.