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CompletedNCT06703619GCS/FOURUpdated Jul 9, 2025

Comparison Between GCS and FOUR Scores

An observational study in Coma, sponsored by Al-Nahrain University. Completed at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Al-Nahrain University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to compare the predictive utility of the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score in determining outcomes among patients with altered mental status admitted to the emergency room. The main questions it aims to answer are:

Does the FOUR Score provide a more accurate prediction of patient outcomes than the GCS Score? Are there specific patient subgroups where one score is more effective than the other?

Participants will:

Undergo assessment of mental status using both the FOUR Score and the GCS Score during their emergency room admission.

Have their clinical outcomes monitored during their hospital stay.

Read the detailed description

The Glasgow Coma Scale (GCS) is commonly used for neurological assessment, but it lacks the precision to cover the full range of consciousness changes.[1]

The GCS is a 15-point scale used to assess consciousness based on three components:

Eye Opening (E):

Spontaneous (4 points) To verbal command (3 points) To pain (2 points) No response (1 point)

Verbal Response (V):

Oriented (5 points) Confused (4 points) Inappropriate words (3 points) Incomprehensible sounds (2 points) No response (1 point)

Motor Response (M):

Obeys commands (6 points) Localizes pain (5 points) Withdrawal to pain (4 points) Abnormal flexion (decorticate posture, 3 points) Abnormal extension (decerebrate posture, 2 points) No response (1 point)

Scoring Range:

15 (best) to 3 (worst). A score ≤8 typically indicates severe brain injury. The Glasgow Coma Scale (GCS) cannot be applied to intubated or aphasic patients because their verbal responses cannot be assessed. Additionally, a withdrawal response to pain can easily be mistaken for a flexion response to pain. While eye-opening indicates wakefulness, it does not necessarily mean that the content of consciousness is intact, as seen in a persistent vegetative state. Furthermore, the GCS does not take into account important factors such as brainstem reflexes, changes in breathing patterns, or the need for mechanical ventilation, all of which could provide a clearer understanding of the coma's severity and offer a more comprehensive neurological assessment.[1-3]

Considering the limitations of the GCS, a new coma scale named the full outline of unresponsiveness (FOUR) score.[2] The scale has been designed to overcome the limitations mentioned above of GCS.

The FOUR score [2] completes it here as it has a higher neurological sophistication. The score is a 16-point scale consisting of four components: eye response, motor response, brainstem reflexes, and respiration.

Eye Response (E):

Eyelids open and tracking (4 points) Eyelids open but not tracking (3 points) Eyelids closed but open to loud voice (2 points) Eyelids closed and open only to pain (1 point) Eyelids closed with no response (0 points)

Motor Response (M):

Obeys commands (4 points) Localizes pain (3 points) Flexion to pain (2 points) Extension to pain (1 point) No response to pain (0 points)

Brainstem Reflexes (B):

Pupillary and corneal reflexes present (4 points) One reflex absent (3 points) Both reflexes absent (2 points) Pupillary reflex absent but corneal reflex present (1 point) No brainstem reflexes (0 points)

Respiration (R):

Not intubated, regular breathing (4 points) Not intubated, Cheyne-Stokes breathing (3 points) Not intubated, irregular breathing (2 points) Intubated and breathing above the ventilator rate (1 point) Intubated and apneic (0 points)

Scoring Range:

16 (best) to 0 (worst).

It can identify states of consciousness other than those approximated by GCS, such as vegetative state and locked-in state. It gives information in regard to respiratory drive and pattern and, therefore, can signal the necessity of mechanical ventilation in the comatose patient. It is more neurologically detailed by featuring brainstem reflexes and respiration components added to the test. It can also categorise the extent of the lowest value to three of the GCS. Hence, it is a more broad-based neurological exam that seems to have better potential to impact early definitive and triage.

Common clinical parameters used for evaluation and management in patients with altered mental status in the Iraqi setting are primarily focused on the use of the Glasgow Coma Scale (GCS) Score, which has been established to be of limited value in evaluating more complex neurological conditions. The Full Outline of Unresponsiveness (FOUR) Score has been proposed internationally as a more comprehensive tool, but its use and validation in the Iraqi population are relatively scarce. This absence of local studies on the comparison between the two scoring systems becomes a major concern as emergency patients may be at risk of the ways coaches devise strategies. The purpose of this study is to fill this gap by investigating and comparing the prognostic abilities of the FOUR Score and the GCS Score in Iraqi Emergency Room patients. Thus, the study aims at presenting information that may help decide when to implement better assessment tools that would ultimately improve patient care for those with the altered mental status.

02

Conditions studied

  • Coma

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Keywords

  • GCS
  • FOUR score
  • COMA
03

In context

Coma

138 studies on the registry are indexed under Coma; 35 are open to participants now.

This study's enrollment of 240 is above the median of 100 across 58 observational studies indexed under Coma.

Browse Coma studies →

Lead sponsor

Al-Nahrain University is the lead sponsor of 26 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include adult patients (aged 18 years and above) presenting to the emergency room with altered mental status due to various underlying conditions, such as traumatic brain injury, metabolic encephalopathy, stroke, or central nervous system infections.

Participants will be selected from a tertiary care hospital emergency room where comprehensive medical and neurological assessments are routinely conducted. This population is expected to represent a diverse range of clinical presentations and severities of altered consciousness, making it suitable for evaluating the predictive performance of the Full Outline of Unresponsiveness (FOUR) score and the Glasgow Coma Scale (GCS).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients admitted to the emergency room with altered mental status.
  • Patients were assessed using both the Full Outline of Unresponsiveness (FOUR) Score and the Glasgow Coma Scale (GCS) Score upon admission.
  • Patients whose clinical outcomes (e.g., mortality, length of hospital stay, need for intensive care) are available for follow-up and analysis.

Exclusion criteria

Exclusion Criteria:

  • Patients with incomplete or missing data on FOUR and/or GCS assessments.
  • Patients who leave against medical advice (LAMA) or are discharged before outcome data can be collected.
  • Patients with pre-existing neurological conditions that might independently influence outcomes (e.g., severe dementia, long-standing neurodegenerative diseases).
  • Patients in whom resuscitative measures were initiated but unsuccessful before scoring could be performed.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. In hospital mortality

    Mortality (death) during hospitalization

    Time frame: average of 10 days through discharge

  2. Accuracy Assessment of the Glasgow Coma Scale (GCS)

    Glasgow Coma Scale (GCS): Range 3-15; higher scores indicate better neurological status.

    Time frame: the first 12 hours after ER admission

  3. Accuracy Assessment of the Full Outline of UnResponsiveness (FOUR) Score

    Full Outline of Unresponsiveness (FOUR) score: Range 0-16; higher scores indicate better neurological status.

    Time frame: the first 12 hours after ER admission

Secondary outcomes

  1. Length of Hospitalization

    The total duration of a patient's stay in the hospital, measured from the date of admission to the date of discharge. This includes all days spent in general wards, intensive care units (ICU), and other hospital departments as part of their treatment course.

    Time frame: average of 10 days through discharge

07

Study locations

1 site
  • College of Medicine - Al-Nahrain University
    Baghdad, Iraq
08

References and documents

Publications

  • Fischer M, Ruegg S, Czaplinski A, Strohmeier M, Lehmann A, Tschan F, Hunziker PR, Marsch SC. Inter-rater reliability of the Full Outline of UnResponsiveness score and the Glasgow Coma Scale in critically ill patients: a prospective observational study. Crit Care. 2010;14(2):R64. doi: 10.1186/cc8963. Epub 2010 Apr 14. PubMed 20398274 ↗
  • Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611. PubMed 16178024 ↗
  • Segatore M, Way C. The Glasgow Coma Scale: time for change. Heart Lung. 1992 Nov-Dec;21(6):548-57. PubMed 1447002 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2024 to primary completion in Jul 2025, 14 months.

Of 24 observational studies under Coma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2024
First posted
Nov 25, 2024
StartActual
May 1, 2024
Primary completionActual
Jul 1, 2025
CompletionActual
Jul 3, 2025
Last update
Jul 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06703619
Lead sponsor
Al-Nahrain University
Responsible party
Abdul-Ilah R. Khamis (Principal Investigator, Al-Nahrain University) — Principal investigator
First posted
Nov 25, 2024
Start date
May 1, 2024
Primary completion
Jul 1, 2025
Completion
Jul 3, 2025
Last update
Jul 9, 2025

Study contacts

Hasan Azeez Al-Hamadani, Professor of Neurology
study chair · College Of Medicine - Nahrain University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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