Laser Light Cues for Gait Freezing in Parkinson's Disease

June 16, 2017 updated by: David K. Simon, Beth Israel Deaconess Medical Center

An Open Label Study to Assess the Efficacy of Visual Cues in the Form of the Laser Cane or the U-Step Walker With Laser Accessory in Parkinson's Disease Patients Who Experience Freezing of Gait.

The purpose of this study is to gather data to see if the Laser Cane and/or U-Step Walker with laser accessory is more effective in aiding with gait freezing than a regular cane/U-Step Walker in patients who have idiopathic Parkinson's disease.

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.

Detailed Description

Freezing of gait is a significant clinical problem in Parkinson's disease (PD). It interferes with daily functioning and quality of life and often results in falls that potentially can inflict serious injury. In recent years, much more attention has been focused on the clinical characteristics of gait freezing, the severity of falls that can result, and the use of visual cues as a possible treatment in order to understand the implications of episodic freezing. Few clinical studies have been done to confirm the clinical observations to date. The laser cane is a device that has been used and prescribed in movement disorder centers as the only form of treatment for freezing of gait. Although it has been shown to be effective in many cases, there is no published data to support what has been observed in the clinic. The proposed study seeks to clarify unanswered questions regarding the laser cane and its efficacy in aiding with episodic gait freezing and falls.

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.
32

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

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New York
      • New York, New York, United States, 10032
        • The Neurological Institute of New York at Columbia University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects or a designated proxy have given informed consent
  • Subject has been diagnosed with idiopathic Parkinson's disease
  • Subject is ambulatory. If a wheelchair is used part-time, it must be used for less than 50% of the time
  • Positive assessment for Questionnaire Used to Identify Freezing of Gait in PD Patients at subject's best "on"

Exclusion Criteria:

  • Presence of atypical features suggestive of MSA, PSP, ataxia, unexplained or prominent pyramidal signs, and/or autonomic dysfunction
  • Subjects who are non-ambulatory more than 50% of the time
  • Subjects who have had a history of syncope in the 6 months prior to screening
  • Subjects with moderate or advanced dementia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: 1 mo baseline
1 mo baseline before visual cue: Cane or walker, no laserlight visual cue x 1 mo; + laserlight visual cue for 2nd mo
Device: 1 mo baseline before visual cue
Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory
Other Names:
  • U-Step Walking Stabilizer
No Intervention: 2 month baseline
Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo

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
Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.
Time Frame: 2-3 months
The FOGQ has a minimum of 0 and max of 4 for each question, with 4 representing more severe freezing of gait. There are 6 questions, so the total score ranges from 0 to 24. It was pre-specified that all 26 subjects were treated as a single group with respect to the primary outcome measure regardless of whether or not they had a 1 month or 2 month baseline period.
2-3 months

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
Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature
Time Frame: 2-3 months
Mean change in time to perform the timed gait test with versus without the laser feature from visit 1 to visit 3. It was pre-specified that all 26 subjects would be treated as a single group with respect to the outcome measure regardless of whether or not they had a 1 month or 2 month baseline period
2-3 months
Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.
Time Frame: 2-3 months
Mean change in falls per week for the period between visit 1 and visit 2 (without laserlight visual cue) compared to the period between visit 2 and visit 3 (with the laserlight visual cue).
2-3 months
Percentage Change in Falls
Time Frame: 1 to 2 months
The mean change in fall frequency from the baseline period without the laserlight visual cue compared to the subsequent period during which they used the laserlight visual cue among subjects experiencing at least one fall during the baseline and subsequent study periods. This outcome measure is expressed as a percentage change from the baseline period.
1 to 2 months

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.
Beth Israel Deaconess Medical Center

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: David K Simon, MD, PhD, Beth Israel Deaconess Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
April 1, 2006

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.
June 1, 2009

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.
June 1, 2009

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).
April 28, 2006

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.
April 28, 2006

First Posted (Estimate)

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.
May 3, 2006

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.
July 14, 2017

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.
June 16, 2017

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.
June 1, 2017

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.
  • 2006P000085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Some individual participant data was included in the publication. There is no plan to share additional individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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