Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2018

Interventions

  • Drug: Amantadine hydrochloride
    • 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

Arms, Groups and Cohorts

  • Experimental: study group
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • The Posner Cueing Task
    • Time Frame: up to day 70
    • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Aged 18-50 yrs 2. Patients who were diagnosed with a Diffuse Axonal Injury post TBI 3. Severity of injury was defined as moderate to severe 4. At least 3 months post injury 5. Sufficient cognitive abilities to learn and perform the computerised task. Exclusion Criteria:

1. Pyramidal signs on neurological examination 2. Localised damage demonstrated on CT 3. Contra indication to Amantadine, post traumatic epilepsy, renal failure and patients with known sensitivity to Amantadine 4. Patients who were diagnosed with Parkinson's disease or has a first degree family who was diagnosed with Parkinson's.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Loewenstein Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: yaron sacher, The effect of amantadine of spatial attention in patients with traumatic brain injury – Loewenstein Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.