Sensory Cues for Freezing in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322426
Recruitment Status : Unknown
Verified May 2006 by Austin Health.
Recruitment status was:  Not yet recruiting
First Posted : May 5, 2006
Last Update Posted : June 23, 2006
Information provided by:
Austin Health

Brief Summary:
The purpose of this study is (1) to determine if patient triggered sensory(auditory, visual and tactile) cues can help treat freezing of gait in Parkinson's disease, and (2) to assess if unexpected (randomized) cues are more effective than anticipated ones.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Sensory Cueing Device Not Applicable

Detailed Description:

Freezing of gait (FOG) is defined as a transient halt in motor activity, wherein the patient appears “as if nailed to the floor.” It is a common phenomenon in Parkinson’s disease (PD), both when medications are at their peak (“on state”) and at their lowest effectiveness (“off state”). While “off” FOG often responds to dopaminergic medications, “on” FOG is a difficult to treat, causing significant distress for the patient, and elevating risk of falls and morbidity.

A few small studies have suggested that auditory and visual sensory cues, in the form of continuous stimuli such as a clicking metronome, music, or horizontal lines drawn the floor, may help patients with gait freezing. In this study, we aim to: (1) evaluate if stimuli (including visual, auditory as well as tactile cues) which are present only on patient triggering are effective for FOG in PD; (2) investigate if presentation of unexpected cues, in the form of randomized sensory stimuli, are more effective that anticipated cues.

Participants will include patients diagnosed with PD, stabilized on drug therapy, with adequate vision, hearing, and mentation to respond to cuing, and experiencing “on” FOG. Patients will be evaluated during a single session. A small device which we have developed will be placed around the neck, and emit either repetitive beeping, a flashing line on the floor, or a slight vibration felt over the neck when the patient presses a button on the front panel in response to FOG. Participants will be videotaped walking a 15 m strip with: (1) no cues; (2) auditory cues only; (3) visual cues only; (4) tactile cues only; and (5) randomized cues. The order in which patients receive the cues will be randomized.

A reviewer will watch the videotape with sound off so that they will be blinded to the cues. The Total Time, Freezing Time (duration of walk in which patient experiences freezing, Walking Time (duration of walk during which patient is not experiencing freezing), and Average Duration of Freeze will be recorded for each walk.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease
Study Start Date : July 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Total walking time
  2. Number of freezes
  3. Freeze time – duration of walk in which patient experiences freezing
  4. Walking time – duration of walk during which patient is not experiencing freezing
  5. Average duration of freeze

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Currently living in Melbourne, Australia (note that we cannot respond to enquiries from outside of this area)
  • Confirmed diagnosis of Parkinson’s disease
  • Stabilized drug therapy for at least 1 month prior to the study and during
  • Hearing and vision – Able to identify lines on floor, hear metronome
  • MMSE >24
  • Able to walk independently (with or without a mechanical aid)
  • Able to give informed consent

Exclusion Criteria:

  • Severe comorbidity (joint problems, neuromuscular disorder affecting mobility)
  • Severe dyskinesias

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 identifier (NCT number): NCT00322426

Contact: Kerrie Schoffer, MD 03-9496-2085

Australia, Victoria
Austin Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3084
Principal Investigator: Kerrie Schoffer, MD         
Sponsors and Collaborators
Austin Health
Principal Investigator: Kerrie Schoffer, MD Austin Hospital, Melbourne Australia Identifier: NCT00322426     History of Changes
Other Study ID Numbers: 1-Schoffer
First Posted: May 5, 2006    Key Record Dates
Last Update Posted: June 23, 2006
Last Verified: May 2006

Keywords provided by Austin Health:
Freezing of Gait
Parkinson's Disease
Sensory Cues

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases