RECRUITING

An Ethical Approach to Detecting Covert Consciousness

Conditions

Disorder of Consciousness Disorders of consciousness, Advanced neuroimaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05010265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Michael Young, MD

CONTACT

617-724-6352

Michael.Young@MGH.HARVARD.EDU

Brian Edlow, MD

CONTACT

617-724-6352

bedlow@mgh.harvard.edu

Principal Investigator

Michael Young, MD

PRINCIPAL_INVESTIGATOR

Mass General Brigham

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Michael Young, MD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2025-07

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Disorders of consciousness, Advanced neuroimaging

Additional Relevant MeSH Terms

Disorder of Consciousness