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

University Hospital Center (CHU)

Status: Unknown

Conditions: Parkinson's Disease

Treatments: Behavioral: Neuropsychological evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT02438124

9193-2

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Patient

Experimental group

Description:

Patient with Parkinson's Disease with walking test and neuropsychological evaluation

Treatment:

Behavioral: Neuropsychological evaluation

Contrôle

Experimental group

Description:

normal control with walking test and neuropsychological evaluation

Treatment:

Behavioral: Neuropsychological evaluation