Effect of Amantadine Administration on Spatial Functioning Following Traumatic Brain Injury

Loewenstein Hospital

Status and phase: Unknown; Phase 4

Conditions: Traumatic Brain Injury

Treatments: Drug: Amantadine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02321761

15-12-LOE

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

study group

Experimental group

Description:

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

Treatment:

Drug: Amantadine hydrochloride