Clinical trial NCT05010265: An Ethical Approach to Detecting Covert Consciousness
Official title: An Ethical Approach to Detecting Covert Consciousness: Data-Driven Neuroethics for Consciousness Detection (DECODE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Disorder of Consciousness
Keywords: Disorders of consciousness, Advanced neuroimaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Disorders of consciousness (DoC)

Brief summary: This study aims to develop an ethical approach to developing and deploying novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.

Detailed description: Previous studies of patients with disorders of consciousness (DoC) have suggested that conscious patients may be misdiagnosed as unconscious up to 40% of the time when traditional qualitative bedside examination is used (Schnakers et al. 2009, Van Erp et al. 2015, Fins and Bernat 2018). Given the well-established prognostic relevance of early behavioral recovery of consciousness for long-term functional outcomes (Giacino and Kalmar 1997, Giacino 2004, Portaccio et al. 2018, Faugeras et al. 2018, Pincherle et al. 2019), whether or not a patient is considered to be conscious is often the primary determinant of whether life-sustaining therapy is continued and neurorehabilitation is offered. Recent advances in neuroimaging and electrophysiologic neurotechnologies, including functional magnetic resonance imaging (fMRI) and electroencephalography (EEG), have yielded novel methods to aid in detecting and predicting emergence of consciousness in patients with brain injuries. Despite these unprecedented research advances, little is known about ethical concerns surrounding these novel neurotechnologies, about the phenomenological, ontological and ethical valence of conscious states of being without behaving revealed through their lens, or about the attitudes of clinicians, researchers, patients and caregivers regarding their responsible implementation. This study aims to fill these crucial knowledge gaps and to support the development of an evidence-based strategy for ensuring responsible research and translation of novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.

Eligibility criteria: Inclusion Criteria:

* Patients with prior or ongoing participation as subject in a research study using neurotechnologies for diagnosis and prognosis of disorders of consciousness (DoC) at Mass General Brigham
* Patients capable of understanding and answering questions in English
* Patients cble to provide informed consent
* Patients for whom MRI / EEG are administered for clinical detection of consciousness and/or neuroprognostication
* Family member or surrogate caregiver of patients who previously participated or are currently participating in a research study using neurotechnologies for diagnosis and prognosis of DoC at Mass General Brigham.
* Family Members / Surrogates capable of understanding and answering questions in English
* Family Members / Surrogates able to provide informed consent
* Family member or surrogate caregiver of patients for whom MRI / EEG are administered for clinical detection of consciousness and/or neuroprognostication
* Research Investigators involved with research responsibilities in designing or testing neurotechnologies on patients with DoC.
* Clinicians with clinical responsibilities caring for patients in behaviorally unresponsive state, defined as coma, vegetative state (VS), and low-level minimally conscious state (MCS).
* Selected leaders and advisors (Community and Thought Leaders) from brain injury associations and advocacy organizations, and policy-makers involved in decision-making impacting patients with DoC.

Exclusion Criteria:

None

Primary outcomes:
measure: Surveys and semi-structured interviews
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Mass General Brigham
name: Michael Young, MD
role: PRINCIPAL_INVESTIGATOR
References: