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:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT03325959
Eligibility Criteria:
Inclusion Criteria:
* FMS diagnosis, based on the updated 2016 diagnostic criteria
* previous physical trauma (such as traumatic brain injury)
Exclusion Criteria:
* the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
* active malignancy,
* chronic ongoing infection
* major psychiatric disorders (excluding anxiety)
* Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded
* previous HBOT for any other reason prior to their inclusion;
* Chest pathology incompatible with pressure changes (including active asthma);
* Inner ear disease
* Claustrophobia;
* Inability to perform awake brain MRI test;
* Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.);
* Brain tumors;
* Skull base fractures;
* s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, (Patients suffering from Encephalomalacia per MRI imaging will not be excluded).
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03325959
Study Brief:
Protocol Section:
NCT03325959