Actively Recruiting

Age: 18Years +
All Genders
ID05010265

An Ethical Approach to Detecting Covert Consciousness: Data-Driven Neuroethics for Consciousness Detection

Led by Massachusetts General Hospital · Updated on 2025-09-11

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on patients with disorders of consciousness (DoC), such as coma, vegetative state, or minimally conscious state, where traditional bedside exams may misdiagnose consciousness in up to 40% of cases. The study aims to explore the ethical issues around new neurotechnologies like functional MRI and EEG that help detect hidden consciousness and predict recovery after brain injuries. It seeks to understand the perspectives of clinicians, researchers, patients, and caregivers to support responsible use of these tools. Participants include patients and their family members or caregivers involved in research using these neurotechnologies, as well as clinicians, researchers, and community leaders engaged in brain injury care and policy. The study uses surveys and semi-structured interviews to gather information about attitudes, expectations, and concerns related to sharing uncertain diagnostic data from advanced neurotechnologies. These methods will be conducted over an average of one year. During the study, participants will complete questionnaires and interviews to share their views on ethical and practical aspects of using neurotechnologies in diagnosing and prognosing consciousness. The primary outcome involves analyzing these survey and interview responses throughout the study. The research is observational and includes ongoing monitoring of participants' feedback without administering treatments, with participation lasting about one year on average.

CONDITIONS

Brief Title

An Ethical Approach to Detecting Covert Consciousness

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have participated or are participating in neurotechnology research for diagnosing or predicting disorders of consciousness at Mass General Brigham
  • Patients who can understand and respond to questions in English
  • Patients able to give informed consent
  • Patients undergoing MRI or EEG for clinical detection of consciousness or prognosis
  • Family members or surrogate caregivers of such patients who can understand and respond in English and provide informed consent
  • Researchers involved in designing or testing neurotechnologies on patients with disorders of consciousness
  • Clinicians caring for patients in coma, vegetative state, or minimally conscious state
  • Selected leaders and advisors from brain injury organizations and policy-makers involved in decisions affecting patients with disorders of consciousness
Not Eligible

You will not qualify if you...

  • None

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Varies according to clinical evaluations

Participants undergo advanced neurotechnologies such as MRI or EEG to detect consciousness and predict recovery.

1 to 2 visits depending on procedures

Surveillance

Duration - Up to 1 year

Participants including patients, caregivers, clinicians, and researchers complete surveys and semi-structured interviews to share preferences, expectations, and concerns about data-sharing of diagnostic results.

Periodic assessments throughout study duration

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Michael Young, MD

B

Brian Edlow, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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