Traumatic Brain Injury Clinical Trial
Official title:
Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | June 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Sciences | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Hamilton Health Sciences Corporation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiographic Changes | MRI Tractography will be performed to measure the size the of reticular activating system fiber tracts. Specifically, the tracts that project through the posterior thalamus. | At baseline and ninety days or at time of discharge from hospital if occurs earlier. | No |
Secondary | Functional Improvement | Disability Rating Scale Score (at enrolment and at completion of the study). | At ninety days or at time of discharge from hospital if occurs earlier. | No |
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