Parkinson's DiseaseNCT04428931
Attentional Performance in Parkinson Disease
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in the brain. Researchers think there may be a relationship between differences in attention and dopamine in people with PD. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Parkinson's Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 6 Dec 2021
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Asymmetric PD patients
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged 35 - 80 (inclusive)
- Fluent in English
- Right-handed per the Edinburgh Handedness scale
- Able to provide consent
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- Diagnosis of idiopathic Parkinson s disease according to UK Brain Bank criteria
- On dopaminergic therapy to treat Parkinsonian symptoms
- MOCA Score greater than or equal to 24 determined by a NIH neurologist
- Hoehn and Yahr Score less than or equal to 3 determined by a NIH neurologist
- Asymmetric motor symptoms
- Because the goals of the study can be accomplished without involving vulnerable population, we will not include individuals without consent capacity.
- Since the goal is to characterize visuospatial attention deficits in idiopathic PD which is a disease of late adulthood, we will not include children.
- The effects of MRI on fetal development and the health of pregnant women is unknown.
- Therefore, women who are pregnant and breast-feeding will be excluded and women who can become pregnant will be excluded following a positive pregnancy test, if the optional MRI is under consideration.
- The study requires fluency in English in order to completely understand tasks instructions, thus non-English speakers/readers will be excluded.
Who cannot join
- Any current major neurological or psychiatric disorder other than Parkinson s disease, such as, (but not limited to) stroke, dementia, Alzheimer disease, Schizophrenia or Major Depression Disorder
- Inability to provide consent
- Members of the Behavioral Neurology Unit, NINDS
- Left-handed per the Edinburgh Handedness scale
- Primarily axial motor symptoms or symmetrical limb involvement
- Pregnancy
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- Exclusion criteria for MRI
- Presence of metal which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if subject was a welder or metal worker, since small metal fragments may be present in the eye.
- Claustrophobia
- Inability to lie supine comfortably for 1 hour
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Attentional Performance in Parkinson Disease
Background:
Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in the brain. Researchers think there may be a relationship between differences in attention and dopamine in people with PD.
Read more
Objective:
To learn if people with PD that is worse on one side also have differences in how much attention they pay to the two sides of space on their left and right.
Eligibility:
English-speaking, right-handed people age 35-80 with PD.
Design:
Participants will be screened with medical and neurological history and exam, and medicine review.
Participants will have 1 study visit. It will last 7-8 hours. They will stop taking their Parkinson medicine 12 hours before the visit.
Participants will complete questionnaires.
Participants will do tasks on a computer screen. They will judge the middle of lines, react to stimuli, and search and identify items that appear on the screen.
Participants may have functional and structural magnetic resonance imaging (MRI). MRI uses a strong magnetic field and radio waves to take pictures of the brain. During the MRI, participants will lie on a table that slides in and out of the MRI scanner. While inside the scanner, they will look at a cross on a screen, relax, and think about nothing.
Participants will undergo prism adaptation. They will sit in front of a board while their chin rests on a support. They will point to 1 of 2 dots on the board while they wear prism glasses that shift their vision to the left or right....
Read the detailed description
Study Description:
We will investigate the relationship between Dopamine (DA) function and attention in patients with asymmetric Parkinson Disease (PD). We hypothesize that the direction of asymmetry in dopamine (DA) depletion predicts the asymmetry in visual attention.
Objectives:
Primary Objective:
- to study attentional asymmetry in patients with PD. We hypothesize that visual attention in Parkinson will be biased to the visual field contralateral to the least affected hemisphere (i.e. contralateral to the most affected side).
Secondary Objectives:
- to investigate the correlation between feedback learning and visuospatial attention performance in PD. We hypothesize that feedback learning will also be affected according to the most compromised hemisphere. Right hemisphere-predominant PD patients (left-motor predominant), compared to left hemisphere-predominant patients, will exhibit a rightward visuospatial bias and a relative preference for learning from reward, compared to punishment.
- to investigate the effect of prism adaptation on feedback learning and visuospatial attention in PD. This objective is exploratory.
Endpoints:
Primary Endpoint: visuospatial performance on the Landmark Task
Secondary Endpoints: performance on:
- Posner Task
- Visual Search Task
- Attentional blink Task
- Visuospatial performance on the Manual Line Bisection Task
- Reward and Punishment Implicit Feedback Learning Task
- The Attentional Scaling Task
Functional connectivity measured with resting state fMRI.
Study Population:
Sixty patients with asymmetric PD. Any gender, aged 35-80 (inclusive), able to give consent and without a diagnosis of significant illness affecting the central nervous system other than PD.
- Conditions
- Parkinson's Disease
- Keywords
- Functional Connectivity, Visual Attention, Dopamine Depletion, Landmark Test
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Patients with Asymmetric Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional asymmetry
Direction and degree of visuospatial bias on the Landmark task
Measured: 2 months
Secondary outcomes (1)
Feedback learning and visuospatial attention performance
Direction and degree of visuospatial bias on the Manual Line Bisection, Visual Search Posner, Attentional Blink, Reward and Punishment Implicit Feedback Learning, and the Attentional Scaling Tasks
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start6 Dec 2021
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Why it stopped: The pandemic caused a delay in starting the study; PI is leaving.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Eric M Wassermann, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428931
- Sponsor's protocol ID
- 200102
- Other IDs
- 20-N-0102
- Status last verified
- Dec 2021
- First submitted
- 11 Jun 2020
- Last updated
- 10 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Attentional Performance in Parkinson Disease
- ClinicalTrials.gov ID
- NCT04428931
- Acronym / sponsor ID
- 200102
- Conditions
- Parkinson's Disease
- Keywords
- Functional Connectivity, Visual Attention, Dopamine Depletion, Landmark Test
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The pandemic caused a delay in starting the study; PI is leaving.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- 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.
Background:
Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in the brain. Researchers think there may be a relationship between differences in attention and dopamine in people with PD.
Objective:
To learn if people with PD that is worse on one side also have differences in how much attention they pay to the two sides of space on their left and right.
Eligibility:
English-speaking, right-handed people age 35-80 with PD.
Design:
Participants will be screened with medical and neurological history and exam, and medicine review.
Participants will have 1 study visit. It will last 7-8 hours. They will stop taking their Parkinson medicine 12 hours before the visit.
Participants will complete questionnaires.
Participants will do tasks on a computer screen. They will judge the middle of lines, react to stimuli, and search and identify items that appear on the screen.
Participants may have functional and structural magnetic resonance imaging (MRI). MRI uses a strong magnetic field and radio waves to take pictures of the brain. During the MRI, participants will lie on a table that slides in and out of the MRI scanner. While inside the scanner, they will look at a cross on a screen, relax, and think about nothing.
Participants will undergo prism adaptation. They will sit in front of a board while their chin rests on a support. They will point to 1 of 2 dots on the board while they wear prism glasses that shift their vision to the left or right....
Detailed description
Study Description:
We will investigate the relationship between Dopamine (DA) function and attention in patients with asymmetric Parkinson Disease (PD). We hypothesize that the direction of asymmetry in dopamine (DA) depletion predicts the asymmetry in visual attention.
Objectives:
Primary Objective:
- to study attentional asymmetry in patients with PD. We hypothesize that visual attention in Parkinson will be biased to the visual field contralateral to the least affected hemisphere (i.e. contralateral to the most affected side).
Secondary Objectives:
- to investigate the correlation between feedback learning and visuospatial attention performance in PD. We hypothesize that feedback learning will also be affected according to the most compromised hemisphere. Right hemisphere-predominant PD patients (left-motor predominant), compared to left hemisphere-predominant patients, will exhibit a rightward visuospatial bias and a relative preference for learning from reward, compared to punishment.
- to investigate the effect of prism adaptation on feedback learning and visuospatial attention in PD. This objective is exploratory.
Endpoints:
Primary Endpoint: visuospatial performance on the Landmark Task
Secondary Endpoints: performance on:
- Posner Task
- Visual Search Task
- Attentional blink Task
- Visuospatial performance on the Manual Line Bisection Task
- Reward and Punishment Implicit Feedback Learning Task
- The Attentional Scaling Task
Functional connectivity measured with resting state fMRI.
Study Population:
Sixty patients with asymmetric PD. Any gender, aged 35-80 (inclusive), able to give consent and without a diagnosis of significant illness affecting the central nervous system other than PD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD patients | – | –Patients with Asymmetric Parkinson's disease |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Asymmetric PD patients
Key inclusion criteria (16 listed)
- Because the goals of the study can be accomplished without involving vulnerable population, we will not include individuals without consent capacity.
- Since the goal is to characterize visuospatial attention deficits in idiopathic PD which is a disease of late adulthood, we will not include children.
- The effects of MRI on fetal development and the health of pregnant women is unknown.
- Therefore, women who are pregnant and breast-feeding will be excluded and women who can become pregnant will be excluded following a positive pregnancy test, if the optional MRI is under consideration.
- The study requires fluency in English in order to completely understand tasks instructions, thus non-English speakers/readers will be excluded.
Key exclusion criteria (11 listed)
- Any current major neurological or psychiatric disorder other than Parkinson s disease, such as, (but not limited to) stroke, dementia, Alzheimer disease, Schizophrenia or Major Depression Disorder
- Inability to provide consent
- Members of the Behavioral Neurology Unit, NINDS
- Left-handed per the Edinburgh Handedness scale
- Primarily axial motor symptoms or symmetrical limb involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attentional asymmetry
Time frame: 2 months
Direction and degree of visuospatial bias on the Landmark task
1 secondary outcome
Feedback learning and visuospatial attention performance
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Eric M Wassermann, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 16 inclusion and 11 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: withdrawn, as of the sponsor's last update on 10 Dec 2021. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Attentional asymmetry (time frame: 2 months). 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 10 Dec 2021.