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

Primary Purpose

Disorders of Consciousness

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sounds and odors
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disorders of Consciousness focused on measuring vegetative state, minimally conscious state, music, preference

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients behavior

healthy volunteers behavior

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cognitive Function measured using the Coma Recovery Scale
Improvement of the score following sound stimuli and/or preferred stimuli

Secondary Outcome Measures

Reaction time
Faster reaction following sound stimuli and/or preferred stimuli

Full Information

First Posted
April 26, 2016
Last Updated
November 28, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02759068
Brief Title
Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)
Acronym
COGNICOMA
Official Title
Beneficial Effects of Preference on Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorders of Consciousness
Keywords
vegetative state, minimally conscious state, music, preference

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients behavior
Arm Type
Experimental
Arm Description
Behavior (motor reaction) to stimuli (sounds and odors)
Arm Title
healthy volunteers behavior
Arm Type
Active Comparator
Arm Description
Behavior (motor reaction) to stimuli (sounds and odors)
Intervention Type
Behavioral
Intervention Name(s)
sounds and odors
Intervention Description
presentation of sounds and odors
Primary Outcome Measure Information:
Title
Cognitive Function measured using the Coma Recovery Scale
Description
Improvement of the score following sound stimuli and/or preferred stimuli
Time Frame
within the first 30 days
Secondary Outcome Measure Information:
Title
Reaction time
Description
Faster reaction following sound stimuli and/or preferred stimuli
Time Frame
within the first 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique
City
Saint Genis Laval
ZIP/Postal Code
69230
Country
France

12. IPD Sharing Statement

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

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