Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT05739734
Eligibility Criteria:
Inclusion Criteria:
* Signature of the Free and Informed Consent Term by the participant or legal guardian
* Age between 18 and 70 years old;
* Thoracic spinal cord injury between T2 and T10, with surgical indication, occurred less than 72 hours before surgery;
* Presence of bulbo cavernosum reflex;
* Patients with a lesion classified as ASIA A according to the ISNCSCI (2019 revision);
Exclusion Criteria:
* Absence of bulbocavernous reflex up to 72 hours after the trauma.
* Presence of severe brain trauma.
* Patients with lesions above T2 or below T10.
* More than one site of spinal cord injury.
* History of alcohol or illicit drug abuse, as defined by DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition or later).
* Patients who need permanent mechanical respiratory support.
* Polytraumatized patients who, in the investigator's assessment, compromise the neurological evolution.
* Neurological diseases or functional dependence of any etiology prior to the trauma.
* Any other comorbidity that, at the discretion of the investigator, makes it impossible to include the patient in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05739734
Study Brief:
Protocol Section:
NCT05739734