Status:

ACTIVE_NOT_RECRUITING

Evaluation of Essential Metal Metabolism

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Disturbance of Consciousness

Alteration of Metabolism

Eligibility:

All Genders

18+ years

Brief Summary

Disturbance of consciousness (DoC) is a state in which consciousness is altered following brain damage and can manifest in several conditions that result from the loss of regulation of the neural func...

Eligibility Criteria

Inclusion

  • Patients who have been in a coma state, documented with a GCS ≤ 8 for at least 24 hours;
  • Presence of a disturbance of consciousness, identified through the Coma Recovery Scale-revised (CRS-r) and classified as coma, vegetative state or minimally conscious state;
  • Latency of the acute event between 15 days and 6 months;
  • Ability of the caregiver/guardian to understand and sign the informed consent.

Exclusion

  • Age \<18 years;
  • Psychiatric or other pathologies;
  • Inflammatory state related to ongoing infections;
  • Refusal or inability to sign the written informed consent to participate in the study.

Key Trial Info

Start Date :

March 17 2025

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 31 2027

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06911515

Start Date

March 17 2025

End Date

March 31 2027

Last Update

April 9 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

UOC Neuroriabilitazione ad alta intensità , Policlinico "A. Gemelli"

Roma, RM, Italy, 00168