MedTrace Logo

Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

NCT02566720 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-11

No results posted yet for this study

Summary

This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.

Conditions

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Pankaj E Bansal, MD · Hamilton Health Sciences Corporation

  • Seyed Hosseini, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566720 on ClinicalTrials.gov