Speed of Processing Training in Patients With Parkinson's Disease and Healthy Older Adults

NCT ID: NCT02929758

Last Updated: 2018-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-02-28

Brief Summary

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The purpose of this prospective, within-subject randomized cross-over design study is to determine if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment. Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. This study will determine if SOPT improves pedestrian behavior in patients with Parkinson's disease and healthy older adults and evaluate the persistence of the SOPT training effects.

Detailed Description

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Pedestrian injury poses significant risk to healthy older adults and patients with Parkinson's disease. Several age-related changes, including slowing of visual processing speed, increase risky pedestrian behavior. Persons with Parkinson's disease (PD) are at even higher risk of pedestrian injury due to motor and non-motor symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by motor symptoms including slowness, tremor, stiffness, and balance problems. Visual processing speed abnormalities, anxiety, and cognitive problems are common non-motor symptoms.

The Useful Field of View (UFOV®) test is a measure of visual processing speed. The UFOV® test is performed on a touch-screen computer that displays objects in the central and peripheral visual fields for brief durations. Successful performance on the test requires integration of visual sensory information and higher-order cognitive processing. Our own research has shown that the UFOV® test performance correlates with pedestrian behavior in PD patients.

Speed of Processing Training (SOPT) is a computer-based training that uses visual exercises to improve cognitive processing. The training involves identifying and localizing visual information quickly in increasingly demanding visual displays. SOPT has been demonstrated to improve performance on the UFOV test in healthy older adults and PD patients. It is hypothesized that SOPT training will improve pedestrian safety in healthy older adults and PD patients.

In the proposed study, we will use a within-subject, randomized, controlled, cross-over design to evaluate if a computer training program (Speed of Processing Training - SOPT) improves safe pedestrian behavior in patients with Parkinson's disease and in healthy older adults in a virtual reality pedestrian environment and if the effects of training persist long-term.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control Initial Training Group

Healthy Controls will receive initial SOPT training and will be compared against controls in the delayed training group and the PD subjects in the initial training group

Group Type ACTIVE_COMPARATOR

Speed of processing training (SOPT)

Intervention Type BEHAVIORAL

This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.

Control Delayed Training Group

Healthy Controls will receive delayed SOPT training and will be compared against controls in the initial training group and the PD subjects in the delayed training group

Group Type ACTIVE_COMPARATOR

Speed of processing training (SOPT)

Intervention Type BEHAVIORAL

This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.

PD Initial Training Group

PD subjects will received initial SOPT training and will be compared against PD subjects in the delayed training group and the control subjects in the initial training group

Group Type OTHER

Speed of processing training (SOPT)

Intervention Type BEHAVIORAL

This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.

PD Delayed Training Group

PD subjects will receive delayed SOPT training and will be compared against PD subjects in the initial training group and the control subjects in the delayed training group

Group Type OTHER

Speed of processing training (SOPT)

Intervention Type BEHAVIORAL

This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.

Interventions

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Speed of processing training (SOPT)

This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.

Intervention Type BEHAVIORAL

Other Intervention Names

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InSight (registered trademark of Posit Science, Inc.)

Eligibility Criteria

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Inclusion Criteria

* Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
* On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
* Age ≥50 at the time of entry into the study
* Age of onset of Parkinson's disease 45 - 85 years old
* Asymmetric onset of PD
* Progressive motor symptoms of PD
* Hoehn and Yahr stages 1-4
* Ability to walk up and down a single stair step
* Access to a computer with internet


* Age ≥50 at the time of entry into the study
* On stable medications for at least 4 weeks prior to entering the study and expected to not need any medication changes for the duration of the study
* Ability to walk up and down a single stair step
* Access to a computer with internet

Exclusion Criteria

* Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
* Neuroleptic treatment at time of onset of Parkinsonism
* Active treatment with a neuroleptic at time of study entry
* History of multiple strokes with stepwise progression of Parkinsonism
* History of multiple head injuries
* Inability to walk without assistance, including a cane, wheelchair, or walker
* Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaire
* Blindness
* Any medical condition that, based on discretion of the PI, would prevent the subject's ability to participate in the study


* Parkinson's disease or other neurodegenerative disorder
* Inability to walk without assistance, including a cane, wheelchair, or walker
* Cognitive dysfunction that would prevent subject's ability to perform virtual reality simulation, speed of processing training, or complete questionnaires
* Blindness
* Any medical condition that, based on the discretion of the PI, would prevent the subject's ability to participate in the study
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Amy Amara, MD

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Amara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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5P30AG022838

Identifier Type: NIH

Identifier Source: secondary_id

View Link

X150203003

Identifier Type: -

Identifier Source: org_study_id

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