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

NCT02759068 — Not applicable, Completed, 36 participants, Hospices Civils de Lyon

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Beneficial Effects of Preference on Behavior

Registry	NCT02759068, acronym COGNICOMA
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, other
Enrollment	36 (Actual)
Sponsor	Hospices Civils de Lyon (Other)
Conditions	Disorders of Consciousness
Interventions	sounds and odors (Behavioral)
Dates	start 2014-11-01, primary completion 2017-05-01, completion 2017-05-01, first posted 2016-05-03, last updated 2018-11-30
Locations	1 site in France

-Summary

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

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+Arms and interventions

Arm	Type	Interventions	Description
patients behavior	Experimental	Behavioral: sounds and odors	Behavior (motor reaction) to stimuli (sounds and odors)
healthy volunteers behavior	Active comparator	Behavioral: sounds and odors	Behavior (motor reaction) to stimuli (sounds and odors)

sounds and odors (Behavioral): presentation of sounds and odors

+Outcome measures

Primary outcomes

Cognitive Function measured using the Coma Recovery Scale [within the first 30 days]: Improvement of the score following sound stimuli and/or preferred stimuli

Secondary outcomes

Reaction time [within the first 30 days]: Faster reaction following sound stimuli and/or preferred stimuli

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique	Saint-Genis-Laval	France