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

NCT02566720 | Unknown

• 1 other identifier: 0452
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Coma; Persistent Vegetative State; Minimally Conscious State; Traumatic Brain Injury

Keywords

amantadine; tractography; mri; coma; abi; tbi; traumatic brain injury; acquired brain injury

Outcome Measures

Primary Outcomes (1)

• Radiographic Changes

  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.

  At baseline and ninety days or at time of discharge from hospital if occurs earlier.

Secondary Outcomes (1)

• Functional Improvement

  At ninety days or at time of discharge from hospital if occurs earlier.

Study Arms (1)

Treatment and MRI scanning

OTHER

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; Procedure: MRI Tractography Study

Interventions

Amantadine DRUG

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.

Also known as: amantadine hydrochloride

Treatment and MRI scanning

MRI Tractography Study PROCEDURE

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.

Treatment and MRI scanning

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Brain Injuries; Coma; Persistent Vegetative State; Brain Injuries, Traumatic

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Pankaj E Bansal, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Seyed Hosseini, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankaj Bansal, MD

CONTACT

9055748515; bansalp@hhsc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 2, 2015
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

CA (1)