An Ethical Approach to Detecting Covert Consciousness

NCT ID: NCT05010265

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2027-07-31

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.

Conditions

Disorder of Consciousness

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Use of advanced neurotechnologies to detect consciousness and predict recovery

Treating clinicians, family members (caregivers) and patients recovering from a diagnosis of coma, vegetative state, or minimally conscious state minus (i.e. minimally conscious state without language function)

Clinician Questionnaire

Intervention Type: OTHER

Surveys will serve to identify preferences, expectations and concerns among clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through investigative neurotechnologies which will then be systematically evaluated.

Semi Structured Interviews

Intervention Type: OTHER

Semi-structured interviews will further serve to identify preferences, expectations and concerns among patients, surrogates, clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through these investigative neurotechnologies which will then be systematically evaluated.

Interventions

Clinician Questionnaire

Surveys will serve to identify preferences, expectations and concerns among clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through investigative neurotechnologies which will then be systematically evaluated.

Intervention Type: OTHER

Semi Structured Interviews

Semi-structured interviews will further serve to identify preferences, expectations and concerns among patients, surrogates, clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through these investigative neurotechnologies which will then be systematically evaluated.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Young, M.D., M.Phil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Young, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Young, MD

Role: CONTACT

Michael.Young@MGH.HARVARD.EDU

617-724-6352

Brian Edlow, MD

Role: CONTACT

bedlow@mgh.harvard.edu

617-724-6352

Facility Contacts

Michael Young, MD

Role: primary

Michael.Young@MGH.HARVARD.EDU

Other Identifiers

1F32MH123001-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2021p001738

Identifier Type: -

Identifier Source: org_study_id