Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

Brief 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.

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

Detailed 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.


Layout table for study information
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years - 65 years
  • 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:

  • Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
  • 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)

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Pankaj Bansal, MD 9055748515 bansalp@hhsc.ca

Locations
Layout table for location information
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Layout table for investigator information
Principal Investigator: Pankaj E Bansal, MD Hamilton Health Sciences Corporation
Principal Investigator: Seyed Hosseini, MD Hamilton Health Sciences Corporation

Layout table for additonal information
Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT02566720     History of Changes
Other Study ID Numbers: 0452
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Hamilton Health Sciences Corporation:
amantadine
tractography
mri
coma
abi
tbi
traumatic brain injury
acquired brain injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Amantadine
Brain Injuries
Brain Injuries, Traumatic
Persistent Vegetative State
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents