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

Brain Injuries, Traumatic Clinical Trial

— RESPONSE 2  

Official title:

Advanced MRI and EEG to Predict Recovery of Consciousness After Severe Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504709
• Other study ID #: 2012P000784
• Status: Completed
• Start date: September 5, 2018
• Est. completion date: October 23, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 23, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients:

Inclusion Criteria:

• 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

Exclusion Criteria:

• History of prior severe brain injury or dementia

• Emergence from MCS at time of initial CRS-R assessment

Healthy Subjects:

Exclusion Criteria:

History of brain injury or neurological disease, psychiatric disease, or any history of diabetes, high blood pressure, heart disease, or kidney disease

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Coma
• Consciousness Disorder
• Consciousness Disorders

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Cortex. 2023 May;162:136-139. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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