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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT03814356
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Severe, acute traumatic brain injury
3. Diagnosis of Coma, Vegetative State, or Minimally Conscious State
Exclusion Criteria:
1. Penetrating brain injury caused by a metallic missile/object (e.g. bullet)
2. Body metal contraindicating MRI
3. Prisoner or ward of the state
4. Neurological
1. Bilateral dilated unresponsive pupils
2. Intracranial hypertension (Intracranial Pressure \[ICP\] \> 25 mmHg for \> 5 min within past 24 hours with head-of-bed at standard clinical angle of 30-45 degrees)
3. Intracranial bolt
4. Status epilepticus or concern for post-ictal state
5. Cardiovascular
1. Poorly controlled hypertension (SBP \> 200 mmHg of DBP \> 120mmHg for 30 minutes, despite anti-hypertensive therapy, within the past 24 hours)
2. Coronary artery disease
3. ST elevation myocardial infarction
4. Acute coronary syndrome
5. Hemodynamically significant dysrhythmia
6. Congestive heart failure
7. Cardiomyopathy (including Takotsubo cardiomyopathy)
8. Other severe structural cardiac abnormalities
6. Renal
a. Renal failure requiring renal replacement therapy (e.g. CVVH or HD)
7. Endocrine
a. History of or clinical suspicion for thyrotoxicosis
8. Reproductive
a. Pregnancy
9. Ophthalmologic
a. History of glaucoma
10. Pharmacologic
a. Monoamine oxidase inhibitor therapy within past 14 days
11. Other
1. Any condition or finding that in the judgment of the PI or treating clinical team significantly increases the risk or significantly decreases the likelihood of a response to IV MPH
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03814356
Study Brief:
Protocol Section:
NCT03814356