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Completed

NCT Number: NCT06770348

Investigating the Localization of Consciousness Through Patients with Disorders of Consciousness: Anterior Vs. Posterior Cortex Debate

Patients enrolled in the study underwent five assessments using the CRS-R(Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET scan.

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Key information

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The enrolled patients were from Shanghai Yongci Rehabilitation Hospital, The Second People's Hospital of Hefei , and the First Affiliated Hospital, Zhejiang University school of Medicine.

Shanghai, Shanghai Municipality, China

About this study

Patients enrolled in the study underwent five assessments using the CRS-R (Coma Recovery Scale-Revised) within 10 days, along with an 18F-FDG-PET (18F-fluorodeoxyglucose-positron emission tomography) scan. The CRS-R evaluations were conducted by professionally trained and highly experienced personnel. During the CRS-R assessments, patients' behavioral responses were recorded in the domains of visual, auditory, motor, oromotor/verbal, communication, and arousal. Based on the optimal CRS-R results obtained within the 10-day period, patients were categorized into MCS (Minimally consciousness state, criteria: consistent command-following, reproducible responses to commands, object recognition, intelligible verbalization, partially accurate communication, object localization, visual pursuit and visual object localization, spontaneous motor responses, object manipulation, and/or localization to noxious stimulation) or UWS (Unresponsive wakefulness syndrome, criteria: preserved wakefulness accompanied by behavioral responses such as localization to sound, auditory startle, visual startle, withdrawal/flexion movements, abnormal posturing, vocalizations/oromotor movements, and reflexive oromotor responses). All patients exhibited stable vital signs. For data analysis, a healthy control group from Belgium was included to compare brain metabolism between patients with disorders of consciousness and healthy individuals.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed diagnosis of disorders of consciousness after 5 CRS-R assessments;
  • Age >18 years;
  • Stable vital signs;
  • No use of sedatives or neuromuscular blockers within 24 hours prior to enrollment.

Exclusion criteria

  • Acute-phase patients (injury duration <28 days);
  • Fewer than 5 CRS-R assessments completed within 10 days;
  • Patients diagnosed with EMCS (Emerging Minimally Conscious State);
  • Patients with unclear diagnoses (cases where experienced evaluators could not reach a consensus diagnosis);
  • Patients with persistent seizures.

Treatment and study plan

Primary outcomes

  1. Brain metabolism in patients with disorders of consciousness was measured by 18F-FDG-PET

    Time frame: From enrollment to the end of CRS-R assessment in 10 days

    Patients were assessed using the CRS-R (Coma Recovery Scale-Revised) five times within 10 days, and an 18F-FDG-PET scan was performed. The assessors for the CRS-R evaluations were professionally trained and highly experienced. During the CRS-R assessment, the patients' behavioral performance in the areas of visual, auditory, motor, oromotor/speech, communication, and arousal were recorded. The patient's best CRS-R assessment score within the 10-day period was used to classify them into MCS (Minimally Conscious State) and UWS (Unresponsive Wakefulness Syndrome).

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

Exploring the Origin of Consciousness Through Disorders of Consciousness: a PET Study"

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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