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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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