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
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ
- Hamilton Health Sciences
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：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.
|
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.
他の名前：
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Radiographic Changes
時間枠：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.
|
At baseline and ninety days or at time of discharge from hospital if occurs earlier.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Improvement
時間枠：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).
|
At ninety days or at time of discharge from hospital if occurs earlier.
|
協力者と研究者
捜査官
- 主任研究者：Pankaj E Bansal, MD、Hamilton Health Sciences Corporation
- 主任研究者：Seyed Hosseini, MD、Hamilton Health Sciences Corporation
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
外傷性脳損傷の臨床試験
-
Zagazig University積極的、募集していないGrade III Traumatic Splenic Injury in Hemodynamically Stable Patientsエジプト