Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT05010265

Conditions

Disorder of Consciousness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Clinician Questionnaire

Semi Structured Interviews

Study Details

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

Study ID

NCT05010265

Start date

Feb 1, 2022

Status verified date

Sep, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

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.

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.

Primary outcome measure

  • Surveys and semi-structured interviews [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Michael Young, MD

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

Brian Edlow, MD

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

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Young, MD

Michael.Young@MGH.HARVARD.EDU

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • Disorders of consciousness, Advanced neuroimaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-11.