Laser Light Cues for Gait Freezing in Parkinson's Disease

NCT00320242 | Completed Results FDA Device

• 1 other identifier: 2006P000085
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; laser cane; freezing of gait; visual cues

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (Visit 1 Until Visit 2) to Endpoint (After Visit 2 Until Visit 3) in the Freezing of Gait Questionnaire Score.

  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 Outcomes (3)

• Mean Change in Time to Perform the Timed Gait Test With vs Without the Laser Feature

  2-3 months

• Mean Change in Number of Falls Without Versus With the Laserlight Visual Cue.

  2-3 months

• Percentage Change in Falls

  1 to 2 months

Study Arms (2)

1 mo baseline

ACTIVE COMPARATOR

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

2 month baseline

NO INTERVENTION

Cane or walker, no laserlight visual cue x 2 mo, + laserlight visual cue for 3rd mo

Interventions

1 mo baseline before visual cue DEVICE

Laser Cane with Laser Accessory and/or U-Step Walker with Laser Accessory

Also known as: U-Step Walking Stabilizer

1 mo baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

The Neurological Institute of New York at Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

• Donovan S, Lim C, Diaz N, Browner N, Rose P, Sudarsky LR, Tarsy D, Fahn S, Simon DK. Laserlight cues for gait freezing in Parkinson's disease: an open-label study. Parkinsonism Relat Disord. 2011 May;17(4):240-5. doi: 10.1016/j.parkreldis.2010.08.010. Epub 2010 Sep 3.

  PMID: 20817535 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. David K. Simon, Associate Professor of Neurology
• Organization: Beth Israel Deaconess Medical Center and Harvard Medical School

dsimon1@bidmc.harvard.edu

617-735-3251

Study Officials

• David K Simon, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: April 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 14, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)