Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
NCT ID: NCT02566720
Last Updated: 2015-12-11
Study Results
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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UNKNOWN
NA
10 participants
INTERVENTIONAL
2016-01-31
2017-06-30
Brief Summary
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Detailed Description
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To determine the size of the RAS tracts as measured by MRI tractography. Specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. The RAS is involved in mediating arousal and consciousness. The size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. It is hypothesized that treatment will result in an increase in the size of these fiber tracts.
As a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. This will allow the clarification and understanding of the technical standards for MRI tractography related to the assessment of the reticular activating system.
Secondary Aim:
To determine and monitor changes in function following acquired brain injury as measured by the Disability Rating Scale (DRS) score. The DRS score will be obtained prior to initiating treatment and at termination of the study. It is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Treatment and MRI scanning
After informed consent has been obtained, the subjects will be examined by a physician and assigned a Disability Ratings Scale (DRS) score. Subjects will undergo MRI tractography study, which does not require the administration of contrast. All participants will receive oral amantadine at escalating doses to ensure tolerance (50mg twice daily for 7 days, then 100mg twice daily for 1 week, then 150mg twice daily, then 200mg twice daily). The usual length of stay on the inpatient brain injury program is ninety days. The MRI tractography study and DRS score will be repeated near the time of discharge or ninety days from enrollment.
Amantadine
Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube. The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily. These are the usual doses and rate of increase that are offered to patients with brain injury.
MRI Tractography Study
Participants will initially receive a baseline MRI Tractography scan. The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.
Interventions
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Amantadine
Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube. The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily. These are the usual doses and rate of increase that are offered to patients with brain injury.
MRI Tractography Study
Participants will initially receive a baseline MRI Tractography scan. The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nonpenetrating acquired brain injury (ABI)
* Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
* Consent from substitute decision maker
Exclusion Criteria
* Anticipated neurosurgical intervention
* Medical instability including uncontrolled hypertension, fever, or infection
* Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
* Parkinson's disease
* History of heart failure or pre-existing peripheral oedema
* History of eczematoid dermatitis
* History of angle-closure glaucoma
* History of neuroleptic malignant syndrome
* Current treatment with Amantadine
* Impairment related to other neurologic disease other than ABI
* Allergy to Amantadine
* Pregnancy or lactation
* Impairment of renal function (creatinine clearance less than 60ml/min)
18 Years
65 Years
ALL
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Pankaj E Bansal, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Seyed Hosseini, MD
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation
Locations
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Hamilton Health Sciences
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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0452
Identifier Type: -
Identifier Source: org_study_id