The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait
|First Received Date ICMJE||February 18, 2010|
|Last Updated Date||February 19, 2014|
|Start Date ICMJE||February 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The change of BOLD-MRI signals and the functional connectivity of the activated regions during different conditions and between groups|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01071590 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Vividness of Movement Imagery Questionnaire (VMIQ) score (Isaac A, 1986) will also be collected as a secondary outcome measure.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait|
|Official Title ICMJE||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 Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Parkinson Disease|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||January 2014|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients in the FOG group and the non-FOG group will be matched by clinical disease stage.
|Ages||40 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01071590|
|Other Study ID Numbers ICMJE||100057, 10-N-0057|
|Has Data Monitoring Committee||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP