Amantadine & Functional Improvement Following ABI Measured by MRI

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Primary Aim:

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02566720
Study type	Interventional
Source	Hamilton Health Sciences Corporation
Contact	Pankaj Bansal, MD
Phone	9055748515
Email	bansalp@hhsc.ca
Status	Not yet recruiting
Phase	N/A
Start date	January 2016
Completion date	June 2017

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT05503316` - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System	N/A
Completed	`NCT04356963` - Adjunct VR Pain Management in Acute Brain Injury	N/A
Completed	`NCT03418129` - Neuromodulatory Treatments for Pain Management in TBI	N/A
Terminated	`NCT03698747` - Myelin Imaging in Concussed High School Football Players
Recruiting	`NCT05130658` - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training	N/A
Recruiting	`NCT04560946` - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI	N/A
Completed	`NCT05160194` - Gaining Real-Life Skills Over the Web	N/A
Recruiting	`NCT02059941` - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines	N/A
Recruiting	`NCT03940443` - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting	`NCT03937947` - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed	`NCT04465019` - Exoskeleton Rehabilitation on TBI
Recruiting	`NCT04530955` - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)	N/A
Recruiting	`NCT03899532` - Remote Ischemic Conditioning in Traumatic Brain Injury	N/A
Suspended	`NCT04244058` - Changes in Glutamatergic Neurotransmission of Severe TBI Patients	Early Phase 1
Completed	`NCT03307070` - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury	N/A
Recruiting	`NCT04274777` - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn	`NCT04199130` - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI	N/A
Withdrawn	`NCT05062148` - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery	N/A
Withdrawn	`NCT03626727` - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms