Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

• Status: Unknown status
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: Amantadine

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)