NCT01563276

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 26, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2013

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

March 22, 2012

Last Update Submit

September 11, 2019

Conditions

Keywords

Progressive Supranuclear PalsyPSPFallsGaitBalanceParkinson's DiseasePD

Outcome Measures

Primary Outcomes (1)

  • Relative contributions of vestibular and visual information to postural control in PSP

    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.

    Single visit. 2 hours.

Secondary Outcomes (3)

  • Postural Response Latencies

    Single visit. 2 hours.

  • Gait patterns and postural transitions

    Single visit. 10 minutes.

  • Perception of vertical and horizontal references

    Single visit. 2 hours.

Study Arms (3)

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.

Parkinson's Disease

Idiopathic PD according to the UK Parkinson"s Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)

Healthy Control

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OHSU Movement Disorders Clinic Volunteers from the community (Portland, Oregon and surrounding areas)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveParkinson Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersSynucleinopathies

Study Officials

  • Bernadette Schoneberg, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 26, 2012

Study Start

December 1, 2011

Primary Completion

May 10, 2013

Study Completion

May 10, 2013

Last Updated

September 13, 2019

Record last verified: 2019-09

Locations