Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321761
• Other study ID #: 15-12-LOE
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2018
• Source: Loewenstein Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Israel	Loewenstein Rehabilitation Center	Ra'anana

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to day 70