- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01563276
Postural Instability in Progressive Supranuclear Palsy
Postural Instability in Progressive Supranuclear Palsy: Why do Patients With PSP Fall?
The purpose of this study is to better understand why individuals with Progressive Supranuclear Palsy (PSP) fall. Understanding the mechanism of gait and balance dysfunction in individuals with PSP may provide us with important early diagnostic tools, allowing for earlier identification of mobility problems and to better evaluate medical therapies aimed at improving motor disability.
The investigators will recruit 10 PSP, 10 PD and 10 healthy controls for the study. All subjects will be asked to come to the OHSU clinic at the Center for Health and Healing for an initial screening visit. They will meet with the primary investigator to conduct a brief interview and physical examination. In addition, they will be asked to answer questions regarding current and past medical illness, how often they fall and what kinds of medications they are on.
Subjects who agree to participate will come to the Oregon Clinical and Translational Research Institute (OCTRI) at OHSU for balance testing. Subjects will be asked to stand or sit on a movable platform with eyes open or closed. Prior to standing on the platform, the investigators will place 6 small sensors on body which are held in place by velcro straps (one on each wrist, ankles, chest and lower back). The platform will then be moved (tilt or slide) while subjects try to keep their balance. During all of the balance tests described above, body movements will be recorded from the sensors on the subjects' body. This data is directly recorded by a computer and analyzed to help us gain better understanding of the subjects' posture and their ability to remain up right.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria.
- Be able to ambulate and stand unassisted for 5 minutes
- Be able to cooperate with gait and balance testing
- Be able to give informed consent.
Exclusion Criteria:
- Cannot exhibit behavior or have dementia that precludes participation in the protocol
- Cannot have medical or orthopedic illness that, in the investigator's opinion, would impact the patient's postural control or ability to participate in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy Control
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Progressive Supranuclear Palsy
Patients with a diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria.
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Parkinson's Disease
Idiopathic PD according to the UK Parkinson"s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Relative contributions of vestibular and visual information to postural control in PSP
Time Frame: Single visit. 2 hours.
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To gage the relative contributions of vestibular and visual information to postural control in PSP we will measure body sway using two different tests (LOS and SOT) while a patient stands on a movable force plate within a movable visual surround.
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Single visit. 2 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postural Response Latencies
Time Frame: Single visit. 2 hours.
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Subjects will stand on a movable platform with a movable visual surround.
Subjects will be asked to keep their balance while the platform is translated or roated.
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Single visit. 2 hours.
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Gait patterns and postural transitions
Time Frame: Single visit. 10 minutes.
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Subjects will be asked to rise from a chair, walk and turn.
Ambulatory balance will be measured by a time up and go test (TUG).
Six accelerometers will be placed on the subject and will measure parameters including arm swing, number of steps and turn duration.
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Single visit. 10 minutes.
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Perception of vertical and horizontal references
Time Frame: Single visit. 2 hours.
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Subjects will perform two different tasks with their eyes closed while standing and sitting on a force plate that is tilting in the antero-posterior direction.
They will perform the following two tasks: 1. Hold a rod parallel to the gravitional vertical 2. Hold a rod perpendicular to the tilting surface so it remains 90 degrees to the surface at all times.
Six accelerometers will measure lower and upper body tilt.
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Single visit. 2 hours.
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Collaborators and Investigators
Investigators
- Principal Investigator: Bernadette Schoneberg, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Ophthalmoplegia
- Parkinson Disease
- Paralysis
- Supranuclear Palsy, Progressive
Other Study ID Numbers
- IRB00007924
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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