Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)

NCT ID: NCT02759068

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-05-31

Brief Summary

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Preferred music improves cognitive function in patients with disorders of consciousness (DOC). However, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents).

The aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised

Detailed Description

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Conditions

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Disorders of Consciousness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients behavior

Behavior (motor reaction) to stimuli (sounds and odors)

Group Type EXPERIMENTAL

sounds and odors

Intervention Type BEHAVIORAL

presentation of sounds and odors

healthy volunteers behavior

Behavior (motor reaction) to stimuli (sounds and odors)

Group Type ACTIVE_COMPARATOR

sounds and odors

Intervention Type BEHAVIORAL

presentation of sounds and odors

Interventions

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sounds and odors

presentation of sounds and odors

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Disorders of consciousness (Traumatic brain injury, stroke or anoxic encephalopathy)
* Coma diagnosis (Plum and Posner, 1966), vegetative state (Task Force, 1994) or minimally conscious state (Giacino, Ashwal et al. 2002)
* Lack of autonomic crisis since one week minimum
* Medical condition considered stable
* Patients who do not present hearing loss. Peaks I and II of Brainstem Auditory Evoked Potentials (BAEP) will be normal.

Exclusion Criteria

* Hearing Problem
* Uncontrolled Epilepsy
* Autonomic crises
* Medical unstable state
* Pregnant or likely to be (interrogation data) or breastfeeding woman
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique

Saint-Genis-Laval, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01062-45

Identifier Type: OTHER

Identifier Source: secondary_id

2014-882

Identifier Type: -

Identifier Source: org_study_id

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