Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
ID06959212

Investigation of Mnesic Capacities in Patients With a Disorder of Consciousness - MemoDoC

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-13

175

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

I

Institut National de la Santé Et de la Recherche Médicale, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the memory abilities of Intensive Care Unit patients who have a Disorder of Consciousness (DoC) caused by severe brain injury. The study aims to understand different types and stages of memory, including perceptual, episodic, and autobiographical memory, to better assess the cognitive profile of these patients. This research addresses the challenge of diagnosing consciousness levels and seeks to improve neurological prognosis and care by detecting memory processes that are not visible through clinical behavior alone. The study uses advanced physiological tools such as high-density electroencephalography (hdEEG) and electrocardiography (ECG) alongside auditory and olfactory stimuli to evaluate memory formation and retrieval in non-communicating patients over two days in the ICU. It includes protocols to assess new memory encoding and long-term retrieval, as well as the investigation of past autobiographical memories. Patients who have regained consciousness will also participate in interviews and neuropsychological tests to explore their subjective experiences and memory function. Participants will undergo physiological recordings, interviews, and cognitive assessments during and after their ICU stay. The study measures brain and bodily responses to stimuli and collects data on memory recovery through follow-up consultations occurring between three and twelve months post-resuscitation. Machine learning techniques will analyze these data to identify memory markers, and group comparisons will explore differences between DoC subtypes and conscious ICU patients. This comprehensive approach aims to improve diagnosis, guide rehabilitation, and deepen understanding of memory and consciousness interplay.

CONDITIONS

Brief Title

Investigation of Mnesic Capacities in Patients With a Disorder of Consciousness

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with a Disorder of Consciousness not conscious according to the CRS-R scale
  • Age over 15 years and 3 months
  • Signed free and informed consent by a third party (legal guardian or trusted person)
  • Conscious patients in Intensive Care Unit aged over 15 years and 3 months with signed informed consent
  • Patients who have regained consciousness after a Disorder of Consciousness, age over 15 years and 3 months, with signed consent by patient or relative
  • Patients must have been unconscious for at least 3 days according to the CRS-R scale
Not Eligible

You will not qualify if you...

  • Deep sedation due to intracranial hypertension or refractory status epilepticus
  • Previous severe neurodegenerative disease such as Alzheimer's or Lewy body dementia
  • Deafness
  • Patients under guardianship or trusteeship
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 consecutive days

Participants undergo physiological recordings using EEG, ECG, electrodermal, and respiratory activity along with auditory and olfactory stimuli to assess memory processes during altered consciousness in the ICU.

2 visits (in-person) over 2 days

Diagnostic Evaluation

Duration - Between 3 and 12 months after ICU stay

Participants who have regained consciousness participate in semi-structured interviews and neuropsychological assessments to explore memories and subjective experiences of the ICU period.

1 follow-up visit (in-person)

Trial Site Locations

Total: 2 locations

1

APHP, Pitié-Salpêtrière Hospital, Department of Anesthesia and Intensive Care, NeuroSurgery ICU

Paris, France, 75013

Actively Recruiting

2

APHP, Pitié-Salpêtrière Hospital, Department of Neurology, Neuro-ICU

Paris, France, 75013

Actively Recruiting

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Research Team

B

Benjamin Rohaut, MD PhD

T

Thomas Andrillon, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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