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

Disorders of Consciousness Clinical Trial

— COGNICOMA  

Official title:

Beneficial Effects of Preference on Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02759068
• Other study ID #: 2014-882
• Secondary ID: 2014-A01062-45
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: May 2017

Study information

• Verified date: November 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorders
• Disorders of Consciousness

Intervention

Behavioral:
• sounds and odors
presentation of sounds and odors

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reaction time	Faster reaction following sound stimuli and/or preferred stimuli	within the first 30 days