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

Not Applicable

Completed

• Conditions: Disorders of Consciousness
• Interventions: Behavioral: sounds and odors

• Registration Number: NCT02759068
• Lead Sponsor: Hospices Civils de Lyon

Brief 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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-03
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers behavior	sounds and odors	Behavior (motor reaction) to stimuli (sounds and odors)
patients behavior	sounds and odors	Behavior (motor reaction) to stimuli (sounds and odors)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reaction time	within the first 30 days	Faster reaction following sound stimuli and/or preferred stimuli

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique; 🇫🇷 Saint Genis Laval, France