Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Study Overview
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Brief Summary
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Amantadine hydrochloride is one of the drugs given at rehabilitation programs to people who suffered Acquired Brain Injury in order to expedite recovery and improve functioning. A previous study examined the spatially asymmetric allocation of attention in patients with traumatic brain injury (TBI). Patients demonstrated significantly worse performance with leftward than with rightward cross-hemi field shifts of attention. This is reminiscence of neglect patients. This difference was significantly reduced during and following treatment. Our objective is to investigate whether Amantadine Hydrochloride is effective in improving allocation of spatial attention and improving function in people with Traumatic Brain Injury.

Official Title
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Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Drug: Amantadine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-50 yrs Patients who were diagnosed with a Diffuse Axonal Injury post TBI Severity of injury was defined as moderate to severe At least 3 months post injury Sufficient cognitive abilities to learn and perform the computerised task. Exclusion Criteria: Pyramidal signs on neurological examination Localised damage demonstrated on CT Contra indication to Amantadine, post traumatic epilepsy, renal failure and patients with known sensitivity to Amantadine Patients who were diagnosed with Parkinson's disease or has a first degree family who was diagnosed with Parkinson's.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Dosage (mg) Day days 0-14 no drug will be given days 15-21 dosage is 100 mg days 22-28 dosage is 200mg days 29-42 dosage is 400mg days 43-56 dosage is 200mg days 57-70 no drug will be given | Drug: Amantadine hydrochloride<br>* Drug dosages: day 0-14 no drug will be given Days 15-21 100 mg Days 22-28 200 mg Days 29-42 400 mg Days 43-56 200 day 57-70 no drug will be given<br>* Other names: Symmetrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Posner Cueing Task | The study paradigm is based on The Posner Cueing Task, a visual spatial attention task. Identification rates were measured after pre cuing attention to different visual field loci. After pre cuing to a locus 5 degrees into the left or right hemi field, target patterns were presented briefly at the cued location (valid) or on the opposite side (invalid) requiring an attentional shift | up to day 70 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI