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

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Civil Hospices of Lyon

Status

Completed

Conditions

Disorders of Consciousness

Treatments

Behavioral: sounds and odors

Study type

Interventional

Funder types

Other

Identifiers

NCT02759068
2014-882
2014-A01062-45 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

patients behavior
Experimental group
Description:
Behavior (motor reaction) to stimuli (sounds and odors)
Treatment:
Behavioral: sounds and odors
healthy volunteers behavior
Active Comparator group
Description:
Behavior (motor reaction) to stimuli (sounds and odors)
Treatment:
Behavioral: sounds and odors

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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