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New treatment option for Disorders of Consciousness
Official title Investigation of Mnesic Capacities in Patients With a Disorder of Consciousness
ClinicalTrials.gov ID: NCT06959212
What this study is testing
- What it's testing
- Following severe brain damage, some individuals lose partial or total awareness of themselves and their environment, falling into a coma that can evolve towards a Disorder of Consciousness (DoC). Accurately diagnosing the depth of consciousness alteration, and thus characterizing the patient's residual state of consciousness, is a real medical challenge, yet crucial for establishing a neurological prognosis, predicting cognitive outcome, and guiding medical decisions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- Patients suffering from a Disorder of Consciousness:
- Patient not conscious according to the CRS-R scale (Kalmar \& Giacino, 2005)
- Age over 15 years and 3 months
- Free and informed consent signed by a third party (parental authority, trusted support person) Conscious patients (controls) :
- Age over 15 years and 3 months
You likely can't join if
- Deep sedation (Intracranial hypertension, refractory status epilepticus)
- Previous severe neurodegenerative disease (e.g. Alzheimer's disease, Lewy body dementia)
- Deafness
- Patients under guardianship or trusteeship
- Pregnant and breast-feeding women
See the full eligibility criteria
- Patients suffering from a Disorder of Consciousness:
- Patient not conscious according to the CRS-R scale (Kalmar \& Giacino, 2005)
- Age over 15 years and 3 months
- Free and informed consent signed by a third party (parental authority, trusted support person) Conscious patients (controls) :
- Age over 15 years and 3 months
- Cared for in an Intensive Care Unit
- Free and informed consent signature Patients who have regained consciousness after having suffered from a Disorder of Consciousness (if not included during their disorder):
- Age over 15 years and 3 months
- Free and informed consent signature if able, otherwise signature of relative (holders of parental authority for minors)
- Patient who has been unconscious for at least 3 days according to the CRS-R scale
- Deep sedation (Intracranial hypertension, refractory status epilepticus)
- Previous severe neurodegenerative disease (e.g. Alzheimer's disease, Lewy body dementia)
- Deafness
- Patients under guardianship or trusteeship
- Pregnant and breast-feeding women
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.