Memory abilities in people with disorders of consciousness
Investigation of Mnesic Capacities in Patients With a Disorder of Consciousness - MemoDoC
This project tests whether brain (hdEEG) and heart (ECG) signals can reveal new memory formation in ICU patients with disorders of consciousness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT06959212 on ClinicalTrials.gov |
What this trial studies
The study uses bedside high-density EEG and ECG with two auditory protocols to probe perceptual, episodic, and autobiographical memory processes in ICU patients who have a disorder of consciousness. It targets both encoding (memory formation during the DoC) and retrieval (memory reported after recovery) and compares physiological markers during unconscious periods with subjective reports after patients regain consciousness. Participants include non-communicating DoC patients, conscious ICU controls, and patients who recovered consciousness, with data supplemented by semi-structured interviews and psychological scales. The aim is to produce a nuanced profile of memory capacities across types and time windows.
Who should consider this trial
Good fit: Ideal participants are ICU patients aged over 15 with a diagnosed disorder of consciousness (e.g., UWS or MCS), or patients who were unconscious for at least three days and later regain capacity, with consent provided by the patient or a legal proxy.
Not a fit: Patients under deep sedation, with prior severe neurodegenerative disease, with deafness, or not treated at the participating ICUs are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the methods could reveal hidden memories and help improve prognosis and care decisions for patients with impaired awareness.
How similar studies have performed: Previous EEG and neuroimaging work has revealed covert cognition in some DoC patients, but applying hdEEG/ECG auditory protocols specifically to detect memory formation during unconsciousness remains largely exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion criteria: - 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
Where this trial is running
Paris and 1 other locations
- APHP, Pitié-Salpêtrière Hospital, Department of Anesthesia and Intensive Care, NeuroSurgery ICU — Paris, France (Recruiting)
- APHP, Pitié-Salpêtrière Hospital, Department of Neurology, Neuro-ICU — Paris, France (Recruiting)
Study contacts
- Principal investigator: Benjamin Rohaut, MD PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Benjamin Rohaut, MD PhD
- Email: benjamin.rohaut@icm-institute.org
- Phone: 01 84 82 78 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.