Developing ethical methods to detect consciousness in patients
An Ethical Approach to Detecting Covert Consciousness: Data-Driven Neuroethics for Consciousness Detection (DECODE)
Massachusetts General Hospital · NCT05010265
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 type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05010265 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are not involved in neurotechnology studies or cannot provide informed consent may not benefit from this study.
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 performed: While there have been advances in neuroimaging for consciousness detection, this study's focus on ethical considerations in implementation is relatively novel.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Young, MD — Massachusetts General Hospital
- Study coordinator: Michael Young, MD
- Email: Michael.Young@MGH.HARVARD.EDU
- Phone: 617-724-6352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Disorder of Consciousness, Disorders of consciousness, Advanced neuroimaging