Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

NCT ID: NCT02321761

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-12-01

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type EXPERIMENTAL

Amantadine hydrochloride

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Symmetrel

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loewenstein Hospital

OTHER

Sponsor Role lead

Responsible Party

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yaron sacher

The effect of amantadine of spatial attention in patients with traumatic brain injury

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Loewenstein Rehabilitation Center

Raanana, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Sara Lipkin, IRB coordinator

Role: primary

+972-9-7709639

Other Identifiers

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15-12-LOE

Identifier Type: -

Identifier Source: org_study_id

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