ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

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.
ClinicalTrials.gov Identifier: NCT02321761
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
yaron sacher, Loewenstein Hospital

December 17, 2014
December 22, 2014
August 8, 2018
June 2014
December 1, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02321761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Traumatic Brain Injury
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
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

Intervention: Drug: Amantadine hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Same as current
December 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Israel
 
 
NCT02321761
15-12-LOE
Yes
Not Provided
Not Provided
yaron sacher, Loewenstein Hospital
Loewenstein Hospital
Not Provided
Not Provided
Loewenstein Hospital
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP