Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

NCT02321761 | Unknown Phase 4 DMC

• 1 other identifier: 15-12-LOE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Amantadine hydrochloride; Rehabilitation; Acquired Brain Injury; TBI

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

study group

EXPERIMENTAL

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

Drug: Amantadine hydrochloride

Interventions

Amantadine hydrochloride DRUG

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

Also known as: Symmetrel

study group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loewenstein Hospital: lead

Study Sites (1)

Loewenstein Rehabilitation Center

Raanana, Israel

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The effect of amantadine of spatial attention in patients with traumatic brain injury

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

IL (1)