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Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's Disease - BeatPark Study (BeatPark)

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ClinicalTrials.gov Identifier: NCT02438124
Recruitment Status : Unknown
Verified January 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : May 8, 2015
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
Université Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

The beneficial effects of rhythmical auditory stimulation (RAS) on spatio-temporal gait characteristics in Parkinson's disease (PD) are attested by clinical research.

Nonetheless, it is still unclear which auditory information parameters (i.e. complexity, temporal regularity or adaptability to gait) maximize the effectiveness of RAS.

Objectives: To evaluate the beneficial effects of RAS on spatio-temporal gait characteristics in PD patients with gait disorders according to:

  • RAS complexity (i.e. metronome, amplitude modulated noise, music)
  • RAS variability (i.e fixed, random, semi-random)
  • RAS adapted in real-time to gait

Variability study:

To study the impact of RAS variability (i.e fixed, random, semi-random) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.

Adaptability studyTo study the impact of RAS adaptability (i.e fixed, random, adapted in real-time to gait) in 20 PD patients and 20 healthy controls on spatio-temporal gait characteristics with metronome, amplitude noise and music.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Neuropsychological evaluation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Rhythmic Auditory Stimulation Optimalization for Gait Improvement in Parkinson's
Study Start Date : September 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patient
Patient with Parkinson's Disease with walking test and neuropsychological evaluation
 Behavioral: Neuropsychological evaluation
The subjects are submitted in one hearing stimulus while they realize a walking test
Experimental: Contrôle
normal control with walking test and neuropsychological evaluation
 Behavioral: Neuropsychological evaluation
The subjects are submitted in one hearing stimulus while they realize a walking test


Outcome Measures
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Primary Outcome Measures :
  1. gait velocity [ Time Frame: 2 days ]
    evaluation of walking speed between the different conditions


Secondary Outcome Measures :
  1. spatio-temporal gait characteristics [ Time Frame: 2 days ]
    evaluation of other walking parameters between the different conditions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 y.o.
  • to be able to understand the study aims and to agree to participate
  • to have signed the consent form
  • to be registered to social security system
  • to reach the diagnosis criteria of idiopathic PD (Queen Square Brain Bank)
  • gait disorder clinically observable

Exclusion Criteria:

  • pregnant or lactating woman
  • high probability of non-compliance
  • curators , authorship or advisers to person of full age Specific exclusion criteria for PD patients
  • clinical signs of parkinsonian syndrome
  • Mini Mental State Examination < 24/30 Specific exclusion criteria for controls
  • neurological disease
  • gait disorder
Contacts and Locations
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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): NCT02438124


Contacts
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Contact: Valérie Cochen De Cock, MD 06 09 04 35 0 valerie.cochen@gmail.com

Locations
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France
Service de neurologie de la Clinique Beau Soleil Recruiting
Montpellier, France, 34070
Contact: Cochen De Cock Valérie, MD    06 09 04 35 05    valerie.cochen@gmail.com   
CIC Recruiting
Montpellier, France, 34235
Contact: Florence Galtier, Doctor         
Contact: Valérie Cochen De Cock, MD    06 09 04 35 05    valerie.cochen@gmail.com   
Plateau Technique de Rééducation Fonctionnelle (Hôpital Gui de Chauliac) du Recruiting
Montpellier, France, 34235
Contact: Valérie Cochen de cock, MD    06 09 04 35 05    valerie.cochen@gmail.com   
Contact: Sophie Bayard         
Sponsors and Collaborators
University Hospital, Montpellier
Université Montpellier
Investigators
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Principal Investigator: Valérie Cochen De Cock, MD University Hospital, Montpellier
More Information
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Publications of Results:
McIntosh, G.C., Rice, R.R., Hurt, C.P., and Thaut, M.H. (1998). Long-term training effects of rhythmic auditory stimulation on gait in patients with Parkinson's disease. Mov. Disord. Off. J. Mov. Disord. Soc. 13 (supple2), 212.

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02438124    
Other Study ID Numbers: 9193-2
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Montpellier:
Parkinson's disease
Rhythmic auditory stimulation
Gait
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases