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Biofeedback to Ameliorate Freezing of Gait

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259635
First Posted: December 14, 2010
Last Update Posted: December 14, 2010
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.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose
The freezing burden will be quantified in subjects with Parkinson's Disease (PD)before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.

Condition Intervention
Parkinson's Disease Device: Biofeedback auditory stimulation

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Biofeedback-based Motor Learning to Ameliorate Freezing of Gait

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Number of freezing of gait episodes [ Time Frame: 2 hour ]
    Freezing episodes will be counted during lab check.


Secondary Outcome Measures:
  • Duration of freezing episodes [ Time Frame: 2 hours ]
    The duraiton of the freezing episodes will be measured.


Estimated Enrollment: 40
Study Start Date: January 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bio feedback for freezing
When ever freezing occures, a metronom sound will be heard
Device: Biofeedback auditory stimulation
Whenever freezing episodes occures, a metronom sound will be heard.
Other Name: Shimmer

Detailed Description:

The freezing burden will be quantified in subjects with PD before and after 6 weeks of training. Two types of interventions (20 subjects in each group) will be tested: 1) Open-loop group (OLG); 2) Closed-loop group (CLG). Each session of the OLG training includes walking courses aimed at provoking freezing episodes. The experimenter will trigger an auditory rhythmic stimulation (RAS) in walking conditions likely to invoke freezing (e.g., turning) and the subject will learn to synchronize his/her gait with the auditory cues, i.e., to keep the walking pace and coordination and, as a result, to avoid freezing. Similar principles will apply for the CLG training; however, the RAS will be elicited automatically by a device that recognizes an approaching freezing episode.

We anticipate that after intensive training, the central nervous system (CNS) of subjects with PD will be able to anticipate impending freezing episodes based on awareness of the environmental conditions (e.g., an approaching turn) and/or based on sub-conscious response to a deteriorating gait pattern. As a result, an automated motor response that paces and coordinates gait will be internally triggered by the CNS and the approaching freezing episode will be averted. The overall freezing burden will therefore decrease in trained subjects.

  Eligibility

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a diagnosis of PD.
  2. Suffer from the freezing of gait (FOG) symptoms. Subjects must score 2 or more on item #3 of the subjective FOG questionnaire (FOG-Q) and exhibit two or more FOG episodes during a short, functional FOG evaluation procedure that includes FOG-provoking conditions (e.g., turns, doorways) and 5 laps of walking in a figure 8 shaped trajectory.
  3. Able to walk unassisted for at least 5 minutes with ample rest.

Exclusion Criteria:

  1. Having serious co-morbidities or acute illness that would make training inappropriate.
  2. Have had brain surgery.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01259635


Contacts
Contact: Nir Giladi, MD +972-3-6974790 ext 1 ngiladi@tasmc.healht.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Nir Giladi, MD    +972-3-6974790 ext 1    ngiladi@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Nir Giladi, MD Tel-Aviv Sourasky Medical Center
  More Information

Responsible Party: Nir Giladi MD, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01259635     History of Changes
Other Study ID Numbers: 0510-10-TLV
First Submitted: November 4, 2010
First Posted: December 14, 2010
Last Update Posted: December 14, 2010
Last Verified: December 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Parkinson's disease
freezing of gait

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