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

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Speed of processing training (SOPT)

About this trial

This is an interventional prevention trial for Parkinson's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Parkinson's disease Subjects:

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

Exclusion Criteria Parkinson's disease Subjects:

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

Inclusion Criteria Control Subjects:

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 Control Subjects:

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

Sites / Locations

University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Arm Label

Control Initial Training Group

Control Delayed Training Group

PD Initial Training Group

PD Delayed Training Group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Time to contact

Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls

Secondary Outcome Measures

Useful Field of View (UFOV)

Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls

Executive function (MoCA, Trails, Stroop)

Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls

Vigilance

Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls

Full Information

NCT ID

NCT02929758

First Posted

October 7, 2016

Last Updated

March 22, 2018

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT02929758

Brief Title

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

Official Title

The Effect of Speed of Processing Training on Pedestrian Behavior in Patients With Parkinson's Disease and Healthy Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2018 (Actual)

Study Completion Date

February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control Initial Training Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Delayed Training Group

Arm Type

Active Comparator

Arm Description

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

Arm Title

PD Initial Training Group

Arm Type

Other

Arm Description

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

Arm Title

PD Delayed Training Group

Arm Type

Other

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Speed of processing training (SOPT)

Other Intervention Name(s)

InSight (registered trademark of Posit Science, Inc.)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to contact

Description

Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Useful Field of View (UFOV)

Description

Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls

Time Frame

3 months

Title

Executive function (MoCA, Trails, Stroop)

Description

Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls

Time Frame

3 months

Title

Vigilance

Description

Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Parkinson's disease Subjects: 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 Exclusion Criteria Parkinson's disease Subjects: 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 Inclusion Criteria Control Subjects: 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 Control Subjects: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amy Amara, MD, PhD

Organizational Affiliation

University of Alabama at Birmingham

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

12. IPD Sharing Statement

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

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