RecruitingNCT05010265

An Ethical Approach to Detecting Covert Consciousness

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


Sponsor

Massachusetts General Hospital

Enrollment

70 participants

Start Date

Feb 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria1

  • None

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Interventions

OTHERClinician 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.

OTHERSemi 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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05010265


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