Biofeedback to Ameliorate Freezing of Gait

Parkinson's Disease Clinical Trial

Official title:

Biofeedback-based Motor Learning to Ameliorate Freezing of Gait

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01259635
• Other study ID #: 0510-10-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: November 4, 2010
• Last updated: December 12, 2010
• Start date: January 2011
• Est. completion date: November 2011

Study information

• Verified date: December 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nir Giladi, MD
• Phone: +972-3-6974790
• Email: ngiladi[@]tasmc.healht.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Biofeedback auditory stimulation
Whenever freezing episodes occures, a metronom sound will be heard.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of freezing of gait episodes	Freezing episodes will be counted during lab check.	2 hour	No
Secondary	Duration of freezing episodes	The duraiton of the freezing episodes will be measured.	2 hours	No