Beneficial Effects of Preference on Behavior in DOC Patie... | NCT02759068

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

NCT02759068

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 30, 2018Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Disorders of Consciousness

Interventions

sounds and odors

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A01062-45	Other Identifier	ANSM

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Apr 26, 2016

First Submission Date that Met QC Criteria

Apr 28, 2016

First Posted Date

May 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2018

Last Update Posted Date

Nov 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
sounds and odors	Behavioral	presentation of sounds and odors	healthy volunteers behavior patients behavior

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Reaction time	Faster reaction following sound stimuli and/or preferred stimuli	within the first 30 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique		Saint-Genis-Laval		69230	France

Condition Browse Module

MeSH Terms

ID	Term
D003244	Consciousness Disorders
D018458	Persistent Vegetative State

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013016	Sound
D009812	Odorants

Ancestor Terms

ID	Term
D011840	Radiation, Nonionizing
D011827	Radiation
D055585	Physical Phenomena
D004777	Environment

Browse Leaves

Not provided

Browse Branches

Not provided