Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02566720|
Recruitment Status : Unknown
Verified December 2015 by Hamilton Health Sciences Corporation.
Recruitment status was: Not yet recruiting
First Posted : October 2, 2015
Last Update Posted : December 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acquired Brain Injury Coma Persistent Vegetative State Minimally Conscious State Traumatic Brain Injury||Drug: Amantadine Procedure: MRI Tractography Study||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||June 2017|
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.
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.
Other Name: amantadine hydrochloride
Procedure: 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.
- Radiographic Changes [ Time Frame: At baseline and ninety days or at time of discharge from hospital if occurs earlier. ]MRI Tractography will be performed to measure the size the of reticular activating system fiber tracts. Specifically, the tracts that project through the posterior thalamus.
- Functional Improvement [ Time Frame: At ninety days or at time of discharge from hospital if occurs earlier. ]Disability Rating Scale Score (at enrolment and at completion of the study).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566720
|Contact: Pankaj Bansal, MDemail@example.com|
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada|
|Principal Investigator:||Pankaj E Bansal, MD||Hamilton Health Sciences Corporation|
|Principal Investigator:||Seyed Hosseini, MD||Hamilton Health Sciences Corporation|