REsting and Stimulus-based Paradigms to Detect Organized NetworkS and Predict Emergence of Consciousness

NCT03504709 | Completed

• 1 other identifier: 2012P000784
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the utility of advanced magnetic resonance imaging (MRI) and electroencephalographic (EEG) technologies for predicting functional outcomes in patients with severe traumatic brain injury (TBI).

Conditions

Consciousness Disorder; Coma; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• Disability Rating Scale total score

  The Disability Rating Scale (DRS) provides quantitative information regarding functional disability in patients recovering from severe brain injury. The total score on the DRS ranges from 0 to 29 with higher scores indicating a greater degree of disability. DRS subscale scores include eye opening \[score range 0-3\], communication \[score range 0-4\], motor response \[score range 0-5\], cognitive ability for feeding \[score range 0-3\], cognitive ability for toileting \[score range 0-3\], cognitive ability for grooming \[score range 0-3\], level of function \[score range 0-5\], and employability \[score range 0-3\]. Subscale scores are summed to produce the total score.

  6 months post injury

Study Arms (2)

Patient (n=50)

Adults with acute severe traumatic brain injury who undergo advanced neuroimaging and electrophysiological studies while in the intensive care unit and are followed for 6 months post injury.

Healthy (n=25)

Healthy adults with no neurological, psychiatric, or medical disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the intensive care unit for acute severe traumatic brain injury

You may qualify if:

• Traumatic Brain Injury
• Glasgow Coma Scale score of 3-8 within 24 hours, unconfounded by sedation, paralysis, hypoxia, hypotension, hypothermia, or concurrent medical illness
• Clinical evidence of disorder of consciousness defined as coma, VS, or MCS

You may not qualify if:

• History of prior severe brain injury or dementia
• Emergence from MCS at time of initial CRS-R assessment
• Healthy Subjects:
• History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (5)

• Edlow BL, Chatelle C, Spencer CA, Chu CJ, Bodien YG, O'Connor KL, Hirschberg RE, Hochberg LR, Giacino JT, Rosenthal ES, Wu O. Early detection of consciousness in patients with acute severe traumatic brain injury. Brain. 2017 Sep 1;140(9):2399-2414. doi: 10.1093/brain/awx176.

  PMID: 29050383 BACKGROUND

• Bodien YG, Giacino JT, Edlow BL. Functional MRI Motor Imagery Tasks to Detect Command Following in Traumatic Disorders of Consciousness. Front Neurol. 2017 Dec 18;8:688. doi: 10.3389/fneur.2017.00688. eCollection 2017.

  PMID: 29326648 BACKGROUND

• Bodien YG, Chatelle C, Edlow BL. Functional Networks in Disorders of Consciousness. Semin Neurol. 2017 Oct;37(5):485-502. doi: 10.1055/s-0037-1607310. Epub 2017 Dec 5.

  PMID: 29207410 BACKGROUND

• Threlkeld ZD, Bodien YG, Rosenthal ES, Giacino JT, Nieto-Castanon A, Wu O, Whitfield-Gabrieli S, Edlow BL. Functional networks reemerge during recovery of consciousness after acute severe traumatic brain injury. Cortex. 2018 Sep;106:299-308. doi: 10.1016/j.cortex.2018.05.004. Epub 2018 May 12.

  PMID: 29871771 BACKGROUND

• Olchanyi MD, Augustinack J, Haynes RL, Lewis LD, Cicero N, Li J, Destrieux C, Folkerth RD, Kinney HC, Fischl B, Brown EN, Iglesias JE, Edlow BL. Automated MRI Segmentation of Brainstem Nuclei Critical to Consciousness. Hum Brain Mapp. 2025 Oct 1;46(14):e70357. doi: 10.1002/hbm.70357.

  PMID: 41074651 DERIVED

MeSH Terms

Conditions

Consciousness Disorders; Coma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Unconsciousness; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurocritical Care Faculty, Massachusetts General Hospital, Associate Director, Center for Neurotechnology and Neurorecovery (CNTR) Director, Laboratory for NeuroImaging of Coma and Consciousness (NICC)

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 20, 2018
• Study Start: September 5, 2018
• Primary Completion: July 19, 2023
• Study Completion: October 23, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)