Sensory Cues for Freezing in Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Effect of Randomized Patient-Triggered Sensory Cues for Freezing of Gait in Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00322426
• Other study ID #: 1-Schoffer
• Status: Not yet recruiting
• Phase: N/A
• First received: May 3, 2006
• Last updated: June 22, 2006
• Start date: July 2006
• Est. completion date: January 2007

Study information

• Verified date: May 2006
• Source: Austin Health
• Contact: Kerrie Schoffer, MD
• Phone: 03-9496-2085
• Email: Kerrie.SCHOFFER[@]austin.org.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Sensory Cueing Device

Locations

Country	Name	City	State
Australia	Austin Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Austin Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total walking time
Primary	Number of freezes
Primary	Freeze time – duration of walk in which patient experiences freezing
Primary	Walking time – duration of walk during which patient is not experiencing freezing
Primary	Average duration of freeze