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New Consciousness Indicators (NCI)

Validation of New Consciousness Indicators in Conscious Participants

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07786298
Acronym
NCI
Enrollment
100
Registered
2026-08-25
Start date
2026-09-01
Completion date
2027-06-01
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consciousness Assessment

Keywords

Consciousness Assessment, Consciousness Indicators, Additional Signs of Consciousness (ASC)

Brief summary

The assessment of the diagnosis and prognosis of patients with disorders of consciousness (DoC) represents a major clinical and ethical challenge, as it may influence therapeutic decision-making. Despite the use of standardized assessment tools such as the Coma Recovery Scale-Revised (CRS-R), diagnostic errors persist. In order to improve the identification of residual conscious activity, several research studies have focused on identifying and validating new clinical indicators of consciousness. In addition to the items already included in the CRS-R to characterize a minimally conscious state, some behavioral manifestations that are not yet included in current assessment scales are being investigated for their diagnostic potential. Mat et al. (2022) proposed several behavioral indicators, including leg crossing, auditory localization, habituation to the auditory startle reflex, resistance to eye opening, spontaneous blink rate, certain motor behaviors, facial expressions in response to nociceptive stimulation, swallowing or oral intake, and responses to olfactory stimuli. To these indicators, we added other potentially relevant behavioral manifestations, including responses to tickling, anticipation of painful stimulation, and responses to pleasant touch. These different items were grouped into an Additional Signs of Consciousness (ASC) Scale. This scale aims to investigate whether these behavioral manifestations may constitute reliable new indicators of consciousness and contribute to improving the diagnostic and prognostic assessment of patients with DoC. To date, this scale has primarily been used in post-coma patients with DoC. However, it is essential to assess the validity of these indicators in healthy, fully conscious participants. Indeed, the relevance of these signs as indicators of residual consciousness in post-coma patients can only be properly interpreted if they are also observable in conscious individuals. Therefore, the aim of this study is to validate these new indicators of consciousness in conscious participants.

Interventions

None listed

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Adult, French-speaking individuals with no neurological and/or psychiatric disorders or history thereof, and no uncorrected sensorimotor deficits.

Exclusion criteria

* Minors, non-French-speaking individuals, individuals with neurological and/or psychiatric disorders or a history thereof, and individuals with uncorrected sensorimotor deficits.

Design outcomes

Primary

MeasureTime frame
Additional signs of consciousness scalesingle time point

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026