Acquired Brain InjuryNCT02566720
Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
A study testing Amantadine and MRI Tractography Study in people with Acquired Brain Injury and Coma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Brain Injury, Coma, Persistent Vegetative State
- What is being tested?
- Amantadine and MRI Tractography Study
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
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.
Read the 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.
- Conditions
- Acquired Brain Injury, Coma, Persistent Vegetative State, Minimally Conscious State, Traumatic Brain Injury
- Being tested
- Amantadine, MRI Tractography Study
- Keywords
- amantadine, tractography, mri, coma, abi, tbi, traumatic brain injury, acquired brain injury
- Medical subject headings
- Brain Injuries, Coma, Persistent Vegetative State, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmantadineDrug
Also called amantadine hydrochloride
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.
MRI Tractography StudyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Amantadine; Procedure: MRI Tractography Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and ninety days or at time of discharge from hospital if occurs earlier.
Secondary outcomes (1)
Functional Improvement
Disability Rating Scale Score (at enrolment and at completion of the study).
Measured: At ninety days or at time of discharge from hospital if occurs earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankaj E Bansal, MD, Principal investigator, Hamilton Health Sciences CorporationSeyed Hosseini, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566720
- Sponsor's protocol ID
- 0452
- Status last verified
- Dec 2015
- First submitted
- 23 Sep 2015
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
- ClinicalTrials.gov ID
- NCT02566720
- Acronym / sponsor ID
- 0452
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment and MRI scanning | Other | Drug: Amantadine, Procedure: MRI Tractography StudyAfter 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmantadineAlso: amantadine hydrochlorideParticipants 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. | Drug | Treatment and MRI scanning |
| MRI Tractography StudyParticipants 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. | Procedure or surgery | Treatment and MRI scanning |
Primary outcome
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.
1 secondary outcome
Functional Improvement
Time frame: At ninety days or at time of discharge from hospital if occurs earlier.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pankaj E Bansal, MD principal investigator
Hamilton Health Sciences Corporation
Seyed Hosseini, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amantadine and MRI Tractography Study in people with Acquired Brain Injury and Coma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pankaj Bansal, MD (9055748515, bansalp@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Changes (time frame: At baseline and ninety days or at time of discharge from hospital if occurs earlier.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.