Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02321761
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : September 27, 2016
Information provided by (Responsible Party):
yaron sacher, Loewenstein Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Amantadine hydrochloride Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
Study Start Date : June 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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
Other Name: Symmetrel

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02321761

Loewenstein Rehabilitation Center Recruiting
Ra'anana, Israel
Contact: Sara Lipkin, IRB coordinator    +972-9-7709639   
Sponsors and Collaborators
Loewenstein Hospital

Responsible Party: yaron sacher, The effect of amantadine of spatial attention in patients with traumatic brain injury, Loewenstein Hospital Identifier: NCT02321761     History of Changes
Other Study ID Numbers: 15-12-LOE
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by yaron sacher, Loewenstein Hospital:
Amantadine hydrochloride
Acquired Brain Injury

Additional relevant MeSH terms:
Brain Injuries, Traumatic
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents