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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT02566720
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years - 65 years
* Nonpenetrating acquired brain injury (ABI)
* Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
* Consent from substitute decision maker
Exclusion Criteria:
* Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
* Anticipated neurosurgical intervention
* Medical instability including uncontrolled hypertension, fever, or infection
* Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
* Parkinson's disease
* History of heart failure or pre-existing peripheral oedema
* History of eczematoid dermatitis
* History of angle-closure glaucoma
* History of neuroleptic malignant syndrome
* Current treatment with Amantadine
* Impairment related to other neurologic disease other than ABI
* Allergy to Amantadine
* Pregnancy or lactation
* Impairment of renal function (creatinine clearance less than 60ml/min)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02566720
Study Brief:
Protocol Section:
NCT02566720