Disorders of ConsciousnessCOGNICOMANCT02759068
Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)
A study testing sounds and odors in people with Disorders of Consciousness, run by Hospices Civils de Lyon at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorders of Consciousness
- What is being tested?
- sounds and odors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hearing Problem
- Uncontrolled Epilepsy
- Autonomic crises
- Medical unstable state
- Pregnant or likely to be (interrogation data) or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon - Hôpital Henry Gabrielle & Hôpital Neurologique
Saint-Genis-Laval, 69230
About this study
Official title: Beneficial Effects of Preference on Behavior
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
- Conditions
- Disorders of Consciousness
- Being tested
- sounds and odors
- Keywords
- vegetative state, minimally conscious state, music, preference
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sounds and odorsBehavioural
presentation of sounds and odors
| Study group | Role | What they receive |
|---|---|---|
| patients behavior | Experimental | Behavior (motor reaction) to stimuli (sounds and odors) Receives: Behavioral: sounds and odors |
| healthy volunteers behavior | Active comparator | Behavior (motor reaction) to stimuli (sounds and odors) Receives: Behavioral: sounds and odors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function measured using the Coma Recovery Scale
Improvement of the score following sound stimuli and/or preferred stimuli
Measured: within the first 30 days
Secondary outcomes (1)
Reaction time
Faster reaction following sound stimuli and/or preferred stimuli
Measured: within the first 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759068
- Sponsor's protocol ID
- 2014-882
- Other IDs
- 2014-A01062-45
- Acronym
- COGNICOMA
- Status last verified
- Nov 2018
- First submitted
- 26 Apr 2016
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Preference on Behavior
- ClinicalTrials.gov ID
- NCT02759068
- Acronym / sponsor ID
- COGNICOMA / 2014-882
- Conditions
- Disorders of Consciousness
- Keywords
- vegetative state, minimally conscious state, music, preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients behavior | Experimental | Behavioral: sounds and odorsBehavior (motor reaction) to stimuli (sounds and odors) |
| healthy volunteers behavior | Active comparator | Behavioral: sounds and odorsBehavior (motor reaction) to stimuli (sounds and odors) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Hearing Problem
- Uncontrolled Epilepsy
- Autonomic crises
- Medical unstable state
- Pregnant or likely to be (interrogation data) or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sounds and odorspresentation of sounds and odors | Behavioural | healthy volunteers behavior, patients behavior |
Primary outcome
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
1 secondary outcome
Reaction time
Time frame: within the first 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sounds and odors in people with Disorders of Consciousness, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function measured using the Coma Recovery Scale (time frame: within the first 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.