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

NCT02759068 | Completed

• 2 other identifiers: 2014-8822014-A01062-45
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Disorders of Consciousness

Keywords

vegetative state; minimally conscious state; music; preference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reaction time

  within the first 30 days

Study Arms (2)

patients behavior

EXPERIMENTAL

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

Behavioral: sounds and odors

healthy volunteers behavior

ACTIVE COMPARATOR

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

Behavioral: sounds and odors

Interventions

sounds and odors BEHAVIORAL

presentation of sounds and odors

healthy volunteers behavior; patients behavior

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique

Saint-Genis-Laval, 69230, France

Location

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Interventions

Sound; Odorants

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Intervention Hierarchy (Ancestors)

Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

FR (1)