The Influence of Sensory Stimuli on Gait Imagery in Patients With Freezing of Gait

NCT01071590 | Completed

• 2 other identifiers: 10005710-N-0057
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Sensory Input; Gait; Imagery; Parkinson Disease; PD

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD patients with freezing:
• 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.
• Willing and able to be off your PD medications for at least 12 hours for visit 1 and visit 2.
• PD patients without freezing:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8341292 BACKGROUND

• Azulay 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.

  PMID: 10050899 BACKGROUND

• Bartels AL, Leenders KL. Brain imaging in patients with freezing of gait. Mov Disord. 2008;23 Suppl 2:S461-7. doi: 10.1002/mds.21912.

  PMID: 18668627 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: February 1, 2010
• Study Completion: January 3, 2014
• Last Updated: December 9, 2019

Record last verified: 2014-01-03

Locations

US (1)