An Ethical Approach to Detecting Covert Consciousness

NCT05010265 | Recruiting

• 2 other identifiers: 2021p0017381F32MH123001-01
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Keywords

Disorders of consciousness, Advanced neuroimaging

Outcome Measures

Primary Outcomes (1)

• Surveys and semi-structured interviews

  Capture and evaluate salient perspectives, preferences and values surrounding the use of advanced neurotechnologies to detect consciousness and predict recovery

  through study completion, an average of 1 year

Study Arms (1)

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)

Other: Clinician Questionnaire; Other: Semi Structured Interviews

Interventions

Clinician Questionnaire 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.

Use of advanced neurotechnologies to detect consciousness and predict recovery

Semi Structured Interviews 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.

Use of advanced neurotechnologies to detect consciousness and predict recovery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disorders of consciousness (DoC)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michael Young, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Young, MD

CONTACT

617-724-6352; Michael.Young@MGH.HARVARD.EDU

Brian Edlow, MD

CONTACT

617-724-6352; bedlow@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: August 18, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)