The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait
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|ClinicalTrials.gov Identifier: NCT01071590|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : January 15, 2019
|First Submitted Date||February 18, 2010|
|First Posted Date||February 19, 2010|
|Last Update Posted Date||January 15, 2019|
|Study Start Date||February 1, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||The change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01071590 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait|
|Official Title||The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait|
- 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.
- To obtain more information on brain function in individuals with freezing of gait.
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.
We intend to study 46 PD patients (23 with freezing and 23 without).
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.
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|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||January 3, 2014|
|Primary Completion Date||Not Provided|
Patients in the FOG group and the non-FOG group will be matched by clinical disease stage.
|Ages||40 Years to 80 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100057
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 3, 2014|