Effectiveness of Oculomotor Training in Parkinson's Disease

October 28, 2024 updated by: Allen MY Cheong, The Hong Kong Polytechnic University

Oculomotor Deficits in Parkinson's Disease: Enhancing Eye Movement Performance and Dynamic Visual Acuity With Oculomotor Training Using a Pilot Randomized Clinical Trial Design

Parkinson's disease (PD) is a common neurodegenerative disorder which is characterized by both motor and non-motor symptoms and usually affects people aged 50 years or above. Many studies showed eye movement deficits and visual changes in patients with PD.

Previous studies have also indicated that clinical eye movement training could enhance the functional performance of patients with various eye movement problems resulting from ocular and neurodegenerative diseases.

In this study, we will investigate the effectiveness of eye movement training on dynamic vision and functional performance in PD patients with oculomotor deficits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Allen MY Cheong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parkinson's Disease diagnosed by a neurologist or geriatrician with the range of Stage

    1 to 4 (Hoehn and Yahr Classification)

  • Able to speak and comprehend Cantonese dialect
  • Able to travel independently

Exclusion Criteria:

  • Any congenital eye problem (e.g. congenital strabismus or amblyopia in either eye) or any manifest eye diseases (e.g. macular degeneration, glaucoma, etc)
  • Severe medical problems (e.g. stroke)
  • Cognitive impairment (e.g. dementia)
  • Presence of any psychiatric or neurological diseases (apart from Parkinson's disease) or receiving of any psychoactive pharmacological treatment
  • Receiving any medication that is known to affect eye movement and cognitive function
  • Previous formal vision rehabilitation or oculomotor intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Group
Receive 10 sessions of 45-minute (3 sessions per week) in-office leisure activities e.g. simple non-action computer games or board games (e.g. card and chess games) and 10-20 minutes of video watching at home
Other: Control Group
Leisure activities
Active Comparator: Intervention Group
Receive 10 sessions of 45-minute office training (3 sessions per week) and 10-20 minute home training (3 sessions per week) of eye movement training
Other: Oculomotor Training Group
Eye movement training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Smooth Vergence eye movements
Time Frame: Change from baseline at week 4 and change from baseline at week 12
Smooth vergence eye movement is measured using a head-mounted eye tracking while fixating at an approaching target moving at different speeds
Change from baseline at week 4 and change from baseline at week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oculomotor characteristics
Time Frame: Change from baseline at week 4 and change from baseline at week 12

With the use of eye tracking device, eye movement behavior of participants can be measured and analysed while performing the following tasks.

  1. Fixation task - Fixate at stationary target presented on a monitor
  2. Saccade task - Follow and fixate at a random jumping target presented on a monitor
  3. Pursuit task - Follow accurately and steadily on a smooth moving target presented on a monitor
  4. Jump Vergence task - Follow and fixate a jumping target presented in the anterior-posterior plane (jumping from 'far to near' or 'near to far')
Change from baseline at week 4 and change from baseline at week 12
Sentence reading performance
Time Frame: Change from baseline at week 4 and change from baseline at week 12
To evaluate the effectiveness of the interventions on sentence reading using MNREAD charts in Chinese. These charts developed in our laboratory are used to measure the effectiveness of sentence reading in terms of reading speed and critical print size.
Change from baseline at week 4 and change from baseline at week 12
Passage reading performance
Time Frame: Change from baseline at week 4 and change from baseline at week 12
To evaluate the effectiveness of the interventions on passage reading using International Reading speed Test (IReST). IReST is used to evaluate the effectiveness of passage reading performance by measuring the reading speed.
Change from baseline at week 4 and change from baseline at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Berkeley
Chinese University of Hong Kong
Hospital Authority, Hong Kong
Deakin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allen Ming Yan Cheong, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15102717

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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