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Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02321761
Enrollment
10
Registered
2014-12-22
Start date
2014-06-30
Completion date
2018-12-01
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Amantadine hydrochloride, Rehabilitation, Acquired Brain Injury, TBI

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.

Interventions

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

Sponsors

Loewenstein Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The Posner Cueing Taskup to day 70The 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026