Improving Functions in MTBI Patients With Headache by rTMS
2018年2月23日 更新者：VA Office of Research and Development
Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly.
Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear.
Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches.
This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).
調査の概要
状態
完了
条件
詳細な説明
This study will only be conducted at the Veterans Affair hospital in San Diego.
研究の種類
介入
入学 (実際)
29
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92161
- VA San Diego Healthcare System, San Diego, CA
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～50年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or female age between 18 to 50
- History of MTBI based on the clinical diagnostic criteria
- History of headache more than 3 months
- No prior experience of TMS treatment
- Pre-treatment headache intensity M-VAS 30(0-100 scale) and average daily headache NPS 3(0-10 scale)
- At least one headache exacerbation per day
- A normal brain MRI in the past 3 months
Exclusion Criteria:
- Pregnancy
- History of pacemaker implant
- Any ferromagnetic(e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain MRI
- History of dementia, major psychiatric diseases, or life threatening diseases
- Presence of any other chronic neuropathic pain states
- History of seizure
- Pending litigation
- Lack of ability to understand the experimental protocol and to adequately communicate in English
- History of chronic headache prior to the incidence of MTBI
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Transcranial Magnetic Stimulation
Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
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Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
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偽コンパレータ：Sham Transcranial Magnetic Stimulation
Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
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Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
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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 |
|---|---|---|
|
Percent Change in Composite Score of Debilitating Headache (Intensity x Duration x Frequency)
時間枠：Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
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The primary outcome time-point measurement will be averaged from each day the subject is enrolled in the study for each of the 3 time point periods: pre-treatment baseline, 1-week follow-up and 1-month follow-up.
The results depict change in the composite score: intensity (scale of 0-10) x duration (# of hours) x frequency (# headaches per week).
The larger composite score for each subject, the worse the debilitating headaches.
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Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
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Percent Change in Persistent Headache Intensity
時間枠：Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
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The persistent headache measure was assessed through a daily headache log over the course of the subjects participation in the study and averaged for the time point period of baseline, 1-week and 1-month results.
The persistent headache is based on a scale of 0-10, the higher the persistent headache intensity averaged score the worse the persistent headache.
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Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured and averaged.
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Percent Change in Persistent Headache Prevalence
時間枠：Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
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The persistent headache prevalence measure was assessed through a daily headache log over the course of the subjects participation in the study and collected at baseline, 1-week and 1-month.
The persistent headache is defined as having had 3+ continuous headaches over the course of the time point periods and was coded as either yes or no.
The results indicate the percent change in the prevalence of persistent headaches for the subjects at the time points.
A larger reduction percent indicates a larger decrease in subjects with those persistent headaches.
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Subjects will have a total of 9 visits over the span of 3 months, the baseline, 1-week follow-up and 1-month follow up will qualify as a time point at which the outcome is measured.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percent Change in Depression Score From Baseline to 1-Week Post-treatment
時間枠：Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.
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Subjects assessed how their headaches interfered with their mood through the Hamilton Rating Scale for Depression assessment at baseline, 1-week follow-up and 1-month follow-up.
The outcome was measured by adding the score of each question on the assessment and then comparing the averaged scores at the different time points.
The larger the depression score, the more severe the depression.
A larger percent change in depression score indicates a change in the severity of the depression.
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Subjects will have a total of 9 visits over the span of 3 months and 3 of those visits will qualify as a time point at which outcome is measured.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Albert Y Leung, MD、VA San Diego Healthcare System, San Diego, CA
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年5月1日
一次修了 (実際)
2016年9月1日
研究の完了 (実際)
2016年9月1日
試験登録日
最初に提出
2013年9月17日
QC基準を満たした最初の提出物
2013年9月19日
最初の投稿 (見積もり)
2013年9月24日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月26日
QC基準を満たした最後の更新が送信されました
2018年2月23日
最終確認日
2018年2月1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。
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-
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