Parkinson DiseaseNCT01071590
The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait
An observational study of Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s disease, significantly affecting their quality of life. It has been defined as a sudden break or block in the walking motion, or as an inability to start walking. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2010to 3 Jan 2014
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD patients with freezing:
- 40 to 80 years of age with idiopathic PD
- Hoehn and Yahr stage 1-4
- Answer to the FOGQ item 3 range from 3-4 (freezing more than about once a day).
- Existence of FOG documented by a neurologist
- Currently taking medications for PD such as L-DOPA (Sinemet) or dopamine agonists such as Mirapex or ReQuip.
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- Willing and able to be off your PD medications for at least 12 hours for visit 1 and visit 2.
- PD patients without freezing:
- 40 to 80 years of age with idiopathic PD
- Hoehn and Yahr stage 1-4
- Answer to the FOG item 3 is 0 (Never freezes).
- The lack of existence of FOG documented by a neurologist.
- Currently taking medications for PD such as L-DOPA (Sinemet) or dopamine agonists such as Mirapex or ReQuip.
- Willing and able to be off your PD medications for at least 12 hours on one occasion.
- Patients in the FOG group and the non-FOG group will be matched by clinical disease stage.
Who cannot join
- Any active psychiatric disease or evidence of dementia
- Feel uncomfortable being in small, enclosed spaces (claustrophobia) or unable to lie still for an hour, e.g. due to back pain
- Pallidotomy or implanted electrodes and generator for deep brain stimulation
- Pregnancy
- Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during MRI.
- Inability to provide informed consent
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- Unable to walk a 10 meter distance even with help of an assisting device
- Unable or unwilling to withhold PD medications for 12 hours prior to visit 1 and visit 2
- Have a neurologic condition other than PD, such as a brain tumor, stroke, head trauma or a vascular malformation
- Have a dysfunction of vision, such as severe loss of visual acuity, that impairs his/her ability to perform the visual imagery task or to appreciate the virtual reality environment during the treadmill test
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s disease, significantly affecting their quality of life. It has been defined as a sudden break or block in the walking motion, or as an inability to start walking. Although certain neural connections or neurological processes might contribute to FOG, more research is needed to produce consistent findings. Researchers are interested in investigating brain function involved in FOG.
Read more
Objectives:
- To obtain more information on brain function in individuals with freezing of gait.
Eligibility:
- Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s disease.
- Participants must be willing to go off their current Parkinson s disease medications for up to 12 hours at a time.
Design:
- Participants will be divided into two groups: those who do have freezing of gait (more than about once a day) and those who have not experienced this symptom.
- The study will involve a screening visit (1 hour) and a study visit (2 hours).
- During the screening visit, participants will be asked about medical history, and will have physical, neurological, memory, and walking tests.
- Participants should not take their Parkinson's disease medications for 12 hours before the study visit. Participants who cannot come to the clinic safely without their medications will be allowed to stay in the hospital overnight before the visit, and should bring their medications to the study in order to take them as soon as needed after the study.
- Participants will be asked to perform several tasks before the imaging study: (1) walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth while following horizontal lines on the floor, (3) walking 10 yards back and forth while listening to a metronome, and (4) being pushed back and forth in a wheelchair.
- After participants perform the actual tasks, participants will be asked to imagine performing the tasks and fill out questionnaires about how well they can imagine the tasks.
- Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan while imagining the four tasks they have just performed.
Read the detailed description
Objective
Freezing of gait (FOG) is a common and very disabling symptom in Parkinson s disease (PD). It has been defined as a sudden transient break (motor block) in the walking motion or as an inability to generate effective stepping. It significantly affects PD patients, resulting in a decline in Quality of Life (QOL). Although certain neural substrates or neuronal connectivity might contribute to FOG, no consistent findings have been established. Our major goal is to investigate the pathophysiology of the brain as it relates to FOG.
Study population
We intend to study 46 PD patients (23 with freezing and 23 without).
Design
Assuming that certain neural networks or brain regions are associated with FOG, we are planning to investigate its mechanism by measuring the Blood Oxygen Level Dependent (BOLD) effect with functional MRI (fMRI) during motor imagery (MI) of gait in PD patients with and without FOG, and compare the results with each other.
Using a block design in functional magnetic resonance imaging (fMRI), we will examine brain activity and brain connectivity of PD patients with and without freezing while they execute four tasks: normal gait imagery; gait imagery with lines on the floor (visual cue); gait imagery with sounds of the metronome (auditory cue); and imagery of being moved by the experimenter while sitting in a wheelchair. The last condition is done to control for the visual flow which should be experienced during MI of gait.
It is known that the motor ability of PD patients, both those with and without FOG, improves with exposure to certain visual stimuli. Using a treadmill combined with a virtual reality environment, we will test the effect of different visual stimuli on the gait performance of PD subjects with and without FOG. In particular, we will examine gait performance as it relates to FOG.
Outcome Measures
For the fMRI experiment, the primary outcome measure is the change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups. In addition, the Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.
Another secondary outcome measure involves the treadmill experiment. In this test, the outcome measure is the motion analysis data, such as stride length and speed, which are derived from the VICON system. Using this test, we hope to determine when the FOG phenomenon occurred.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Sensory Input, Gait, Imagery, Parkinson Disease, PD
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups
Secondary outcomes (1)
Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study start1 Feb 2010
- Study completion3 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071590
- Sponsor's protocol ID
- 100057
- Other IDs
- 10-N-0057
- Status last verified
- 3 Jan 2014
- First submitted
- 18 Feb 2010
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Atchison PR, Thompson PD, Frackowiak RS, Marsden CD. The syndrome of gait ignition failure: a report of six cases. Mov Disord. 1993 Jul;8(3):285-92. doi: 10.1002/mds.870080306.
PubMed 8341292Azulay JP, Mesure S, Amblard B, Blin O, Sangla I, Pouget J. Visual control of locomotion in Parkinson's disease. Brain. 1999 Jan;122 ( Pt 1):111-20. doi: 10.1093/brain/122.1.111.
PubMed 10050899Bartels AL, Leenders KL. Brain imaging in patients with freezing of gait. Mov Disord. 2008;23 Suppl 2:S461-7. doi: 10.1002/mds.21912.
PubMed 18668627
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait
- ClinicalTrials.gov ID
- NCT01071590
- Acronym / sponsor ID
- 100057
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Sensory Input, Gait, Imagery, Parkinson Disease, PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 Feb 2010
- Study completion
- 3 Jan 2014
- First posted
- 19 Feb 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.
Background:
- Freezing of gait (FOG) is a common and very disabling symptom in people with Parkinson s disease, significantly affecting their quality of life. It has been defined as a sudden break or block in the walking motion, or as an inability to start walking. Although certain neural connections or neurological processes might contribute to FOG, more research is needed to produce consistent findings. Researchers are interested in investigating brain function involved in FOG.
Objectives:
- To obtain more information on brain function in individuals with freezing of gait.
Eligibility:
- Individuals between the ages of 45 and 80 who have been diagnosed with Parkinson s disease.
- Participants must be willing to go off their current Parkinson s disease medications for up to 12 hours at a time.
Design:
- Participants will be divided into two groups: those who do have freezing of gait (more than about once a day) and those who have not experienced this symptom.
- The study will involve a screening visit (1 hour) and a study visit (2 hours).
- During the screening visit, participants will be asked about medical history, and will have physical, neurological, memory, and walking tests.
- Participants should not take their Parkinson's disease medications for 12 hours before the study visit. Participants who cannot come to the clinic safely without their medications will be allowed to stay in the hospital overnight before the visit, and should bring their medications to the study in order to take them as soon as needed after the study.
- Participants will be asked to perform several tasks before the imaging study: (1) walking 10 yards back and forth down a hallway, (2) walking 10 yards back and forth while following horizontal lines on the floor, (3) walking 10 yards back and forth while listening to a metronome, and (4) being pushed back and forth in a wheelchair.
- After participants perform the actual tasks, participants will be asked to imagine performing the tasks and fill out questionnaires about how well they can imagine the tasks.
- Participants will be monitored with a functional magnetic resonance imaging (fMRI) scan while imagining the four tasks they have just performed.
Detailed description
Objective
Freezing of gait (FOG) is a common and very disabling symptom in Parkinson s disease (PD). It has been defined as a sudden transient break (motor block) in the walking motion or as an inability to generate effective stepping. It significantly affects PD patients, resulting in a decline in Quality of Life (QOL). Although certain neural substrates or neuronal connectivity might contribute to FOG, no consistent findings have been established. Our major goal is to investigate the pathophysiology of the brain as it relates to FOG.
Study population
We intend to study 46 PD patients (23 with freezing and 23 without).
Design
Assuming that certain neural networks or brain regions are associated with FOG, we are planning to investigate its mechanism by measuring the Blood Oxygen Level Dependent (BOLD) effect with functional MRI (fMRI) during motor imagery (MI) of gait in PD patients with and without FOG, and compare the results with each other.
Using a block design in functional magnetic resonance imaging (fMRI), we will examine brain activity and brain connectivity of PD patients with and without freezing while they execute four tasks: normal gait imagery; gait imagery with lines on the floor (visual cue); gait imagery with sounds of the metronome (auditory cue); and imagery of being moved by the experimenter while sitting in a wheelchair. The last condition is done to control for the visual flow which should be experienced during MI of gait.
It is known that the motor ability of PD patients, both those with and without FOG, improves with exposure to certain visual stimuli. Using a treadmill combined with a virtual reality environment, we will test the effect of different visual stimuli on the gait performance of PD subjects with and without FOG. In particular, we will examine gait performance as it relates to FOG.
Outcome Measures
For the fMRI experiment, the primary outcome measure is the change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups. In addition, the Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.
Another secondary outcome measure involves the treadmill experiment. In this test, the outcome measure is the motion analysis data, such as stride length and speed, which are derived from the VICON system. Using this test, we hope to determine when the FOG phenomenon occurred.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients in the FOG group and the non-FOG group will be matched by clinical disease stage.
Key exclusion criteria (10 listed)
- Any active psychiatric disease or evidence of dementia
- Feel uncomfortable being in small, enclosed spaces (claustrophobia) or unable to lie still for an hour, e.g. due to back pain
- Pallidotomy or implanted electrodes and generator for deep brain stimulation
- Pregnancy
- Surgically or traumatically implanted foreign bodies such as a pacemaker, implanted medical pump, implanted hearing aids, metal plate in the skull, or metal implant in the skull or eyes (other than dental appliances or fillings) that may pose a physical hazard during MRI.
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
The change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups
1 secondary outcome
Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.
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 9 Dec 2019.
- Background: PubMed 8341292Atchison PR, Thompson PD, Frackowiak RS, Marsden CD. The syndrome of gait ignition failure: a report of six cases. Mov Disord. 1993 Jul;8(3):285-92. doi: 10.1002/mds.870080306.
- Background: PubMed 10050899Azulay JP, Mesure S, Amblard B, Blin O, Sangla I, Pouget J. Visual control of locomotion in Parkinson's disease. Brain. 1999 Jan;122 ( Pt 1):111-20. doi: 10.1093/brain/122.1.111.
- Background: PubMed 18668627Bartels AL, Leenders KL. Brain imaging in patients with freezing of gait. Mov Disord. 2008;23 Suppl 2:S461-7. doi: 10.1002/mds.21912.
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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.
Mark Hallett, 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 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 15 inclusion and 10 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 9 Dec 2019. 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 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?
The change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071590, which also lists 3 linked publications.
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 9 Dec 2019.