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

Beneficial Effects of Preference on Behavior

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

Study Overview

• Status: Completed
• Conditions: Disorders of Consciousness
• Intervention / Treatment: Behavioral: sounds and odors

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Genis Laval, France, 69230
    • Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients behavior; Behavior (motor reaction) to stimuli (sounds and odors)	Behavioral: sounds and odors; presentation of sounds and odors
Active Comparator: healthy volunteers behavior; Behavior (motor reaction) to stimuli (sounds and odors)	Behavioral: sounds and odors; presentation of sounds and odors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Function measured using the Coma Recovery Scale	Improvement of the score following sound stimuli and/or preferred stimuli	within the first 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction time	Faster reaction following sound stimuli and/or preferred stimuli	within the first 30 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: music; minimally conscious state; preference; vegetative state
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: 2014-882; 2014-A01062-45 (Other Identifier: ANSM)