Back to resultsEffect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Amantadine hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI
Eligibility Criteria
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.
Sites / Locations
- Loewenstein Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02321761
Brief Title
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
Official Title
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loewenstein Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Amantadine hydrochloride
Other Intervention Name(s)
Symmetrel
Intervention Description
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
Primary Outcome Measure Information:
Title
The Posner Cueing Task
Description
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
Time Frame
up to day 70
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Loewenstein Rehabilitation Center
City
Ra'anana
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Lipkin, IRB coordinator
Phone
+972-9-7709639
Email
Mirp3@clalit.org.il
12. IPD Sharing Statement
Learn more about this trial
Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury
We'll reach out to this number within 24 hrs