Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study
Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study
연구 개요
상태
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다
- Hamilton Health Sciences
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
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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.
다른 이름들:
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Radiographic Changes
기간: At baseline and ninety days or at time of discharge from hospital if occurs earlier.
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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.
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At baseline and ninety days or at time of discharge from hospital if occurs earlier.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional Improvement
기간: At ninety days or at time of discharge from hospital if occurs earlier.
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Disability Rating Scale Score (at enrolment and at completion of the study).
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At ninety days or at time of discharge from hospital if occurs earlier.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Pankaj E Bansal, MD, Hamilton Health Sciences Corporation
- 수석 연구원: Seyed Hosseini, MD, Hamilton Health Sciences Corporation
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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