Clinical trial Recruiting at 1 site Observational Ages 18 and up

Developing ethical methods to detect consciousness in patients

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

Run by Massachusetts General Hospital · NCT05010265 · Data updated 2026-11-12

This study is trying to find better and ethical ways to use brain imaging technology to see if patients with disorders of consciousness are actually aware, to help avoid misdiagnosis.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
StatusRecruiting
StartedFebruary 1, 2022
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedSeptember 11, 2025
Trial IDNCT05010265 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with a history of participation in neurotechnology studies for DoC and their family members or caregivers who can provide informed consent.

Probably not a fit

Patients who are not involved in neurotechnology studies or cannot provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on creating an ethical framework for utilizing advanced neuroimaging technologies to identify consciousness in patients with disorders of consciousness (DoC). It addresses the significant issue of misdiagnosis in these patients, where up to 40% may be incorrectly deemed unconscious. The study employs clinician questionnaires and semi-structured interviews to gather insights from patients, caregivers, and healthcare professionals about the ethical implications of these technologies. By exploring these perspectives, the research aims to establish responsible practices for the implementation of neurotechnologies in clinical settings.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of consciousness detection, leading to better prognostic outcomes and treatment decisions for patients with brain injuries.

How similar studies have gone: While there have been advances in neuroimaging for consciousness detection, this study's focus on ethical considerations in implementation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.