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Completed

NCT Number: NCT02759068

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

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

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Key information

Conditions

Disorders of Consciousness Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Persistent Vegetative State Signs and Symptoms Unconsciousness

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique

Saint-Genis-Laval, 69230, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sounds and odors

Behavioral

presentation of sounds and odors

Primary outcomes

  1. Cognitive Function measured using the Coma Recovery Scale

    Time frame: within the first 30 days

    Improvement of the score following sound stimuli and/or preferred stimuli

Secondary outcomes

  1. Reaction time

    Time frame: within the first 30 days

    Faster reaction following sound stimuli and/or preferred stimuli

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Beneficial Effects of Preference on Behavior

Acronym: COGNICOMA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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