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Trial record 11 of 35 for:    Parkinson's disease | Recruiting Studies | NIH

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

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ClinicalTrials.gov Identifier: NCT02929758
Recruitment Status : Recruiting
First Posted : October 11, 2016
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Amy Amara, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment
Parkinson's Disease Behavioral: Speed of processing training (SOPT)

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Speed of Processing Training on Pedestrian Behavior in Patients With Parkinson's Disease and Healthy Older Adults
Study Start Date : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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
Behavioral: 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.
Other Name: InSight (registered trademark of Posit Science, Inc.)
Active Comparator: 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
Behavioral: 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.
Other Name: InSight (registered trademark of Posit Science, Inc.)
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
Behavioral: 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.
Other Name: InSight (registered trademark of Posit Science, Inc.)
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
Behavioral: 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.
Other Name: InSight (registered trademark of Posit Science, Inc.)



Primary Outcome Measures :
  1. Time to contact [ Time Frame: 3 months ]
    Difference in time to contact between baseline and immediate post-training assessments in PD and healthy controls


Secondary Outcome Measures :
  1. Useful Field of View (UFOV) [ Time Frame: 3 months ]
    Difference in UFOV total score between baseline and immediate post-training assessments in PD and healthy controls

  2. Executive function (MoCA, Trails, Stroop) [ Time Frame: 3 months ]
    Difference in MoCA, Trails, and Stroop between baseline and immediate post-training assessments in PD and healthy controls

  3. Vigilance [ Time Frame: 3 months ]
    Differences in vigilance as measured by psychomotor vigilance task between baseline and immediate post-training assessments in PD and healthy controls



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929758


Contacts
Contact: Amy Amara, MD, PhD 205-934-0683 amyamara@uab.edu
Contact: Allen Joop, MS 205-934-5954 allenjoop@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Allen Joop, MS    205-934-5954    allenjoop@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute on Aging (NIA)
Investigators
Principal Investigator: Amy Amara, MD, PhD University of Alabama at Birmingham

Responsible Party: Amy Amara, MD, Assistant Professor of Neurology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02929758     History of Changes
Other Study ID Numbers: X150203003
5P30AG022838 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors