Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Phase 4

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Amantadine hydrochloride

• Registration Number: NCT02321761
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2014-12-19
• Study First Posted: 2014-12-22
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	Amantadine hydrochloride	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

Primary Outcome Measures

Name	Time	Method
The Posner Cueing Task	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

Trial Locations

Locations (1)

Loewenstein Rehabilitation Center; 🇮🇱 Ra'anana, Israel