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CompletedNCT01135407VSA-PDUpdated Nov 22, 2010

Visual Selective Attention in Parkinson's Disease

An observational study in Visual Attention in Parkinson's Disease, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-11-22.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
36
Ages
21 Years and older
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Visual Attention in Parkinson's Disease

Keywords

  • Parkinson's disease
  • Deep brain stimulation
  • Subthalamic nucleus
  • Levodopa
  • Selective visual attention
  • Basal ganglia diseases
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 36 is below the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 835 studies on the registry; 207 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Eligibility criteria

PD patients and healthy controls will be matched for age, sex, and education. PD patients: group #1 e group #2

Inclusion Criteria:

  • 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
  • Able to give and sign the informed consent

Exclusion Criteria:

  • 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

Healthy controls: group #3

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
05

Study design

Time perspective
Prospective
Enrollment
36 participants (actual)

Groups and cohorts

  • group #1

    Parkinson's disease patients at a disease's stage characterized by motor complications

    Other: Recording during computerized tests

  • group #2

    Parkinson's disease patients treated by subthalamic nucleus deep brain stimulation.

    Other: Recording during computerized tests

  • group #3

    healthy controls

    Other: Recording during computerized tests

Interventions

  • OtherRecording during computerized tests

    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.

  • OtherRecording during computerized tests

    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.

  • OtherRecording during computerized tests

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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)

    Time frame: 1 hour for each experimental session. All participants will perform more than one experimental session, on different days within the same week

07

Study locations

1 site
  • Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital
    Grenoble, 38043, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01135407
First posted
Jun 2, 2010
Start date
Oct 2009
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Nov 22, 2010

Study contacts

Pierre POLLAK, Professor
principal investigator · Unité des Troubles du Mouvement, Clinique de Neurologie, Grenoble University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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