心的外傷後ストレス障害におけるMeRT治療の安全性と有効性を評価するための臨床試験 (MeRT-005-B)
2026年1月14日 更新者：Wave Neuroscience
永続的な脳震盪後症状（PPCS）の有無にかかわらず、心的外傷後ストレス障害のバイオメトリクス誘導磁気EEG共鳴療法（MeRT）治療の安全性と有効性を評価するための、前向き、二重盲検、無作為化、シャム制御、臨床試験外傷性脳損傷（TBI）
この研究の目的は、外傷性脳損傷（TBI）後の持続性脳震盪後症状（PPCS）の有無にかかわらず、心的外傷後ストレス障害の個別化されたバイオメトリクス誘導磁気電子共鳴療法（MeRT）治療の安全性と有効性を評価することです。 ）。
調査の概要
詳細な説明
MERT-005-B は、持続的後遺症の有無にかかわらず、心的外傷後ストレス障害のある人における EEG ガイド付き MeRT の有効性を評価するために設計された、前向き、二重盲検、無作為化、シャム対照、並行グループ、層別化、適応臨床試験です。外傷性脳損傷（TBI）後の脳震盪症状（PPCS）。
合計 152 人の参加者がテスト フェーズで無作為に割り付けられ、最大 176 人の参加者の盲検適応サンプル サイズの再評価と、データおよび安全性監視委員会 (DSMB) による有効性モニタリングへのグループ シーケンシャル アプローチが行われます。
パイロットフェーズが完了し、74 人の参加者が無作為化されました。 パイロット フェーズのデータは、MeRT の安全性を確認するために使用されます。 テストフェーズでは、適格な参加者は、MeRT または Sham MeRT 治療グループに 1:1 の割り当て比率でランダムに割り当てられ、募集サイトで層別化され、2 レベルの PPCS 併存疾患 (+/-) が適用されます。
最初の適格性評価とデータ収集は、スクリーニング訪問 (SC) で行われます。 SCの訪問に続いて、5週間の治療期間があり、その中でアクティブまたは偽の調査治療が毎日の平日の訪問中に投与されます 研究サイト。 引き続き適格であるすべての参加者には、さらに2週間の積極的なMeRT研究治療が提供されます。
主な研究結果は、5週間の治療期間の終わりに2回目のフォローアップ訪問（F2）で収集されます。 短縮されたデータ収集訪問は、3 番目の治療週 (F1 フォローアップ訪問) の間に行われます。 追加のフォローアップ訪問は、研究治療の初日から90日後（F3）および180日後（F4）に行われます。
参加者、臨床医、および評価に参加するすべての担当者は、治療グループの割り当てを研究することはできません。
この試験の第 1 段階は、米国特殊作戦司令部 (USSOCOM) およびヘンリー ジャクソン財団と協力して実施されました。
研究の種類
介入
入学 (実際)
158
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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Costa Mesa、California、アメリカ、92626
- BrainHealth Solutions
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Long Beach、California、アメリカ、90822
- VA Long Beach Healthcare System
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San Diego、California、アメリカ、92103
- SoCal Neuroscience Research Unit
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North Carolina
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Raleigh、North Carolina、アメリカ、27607
- UNC Rex Hospital
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Ohio
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Columbus、Ohio、アメリカ、43219
- Columbus Brain Research Center
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Pennsylvania
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Bryn Mawr、Pennsylvania、アメリカ、19010
- Center for Interventional Pain and Spine
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Texas
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Plano、Texas、アメリカ、75093
- Texas A&M Research Center
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Washington
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Bellevue、Washington、アメリカ、98004
- Seattle Neuropsychiatric Treatment Center (Seattle NTC)
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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～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
参加者は、研究への登録資格を得るために、すべての選択基準を満たす必要があります。
- -研究への参加に同意する意思があり、同意できる
- 18～65歳
- CAPS-5によるDSM-V基準によるPTSDの診断
- -PTSD症状のDSM-5基準を満たす症状の発症は、スクリーニング訪問前の最低6か月間持続します
- 30 以上の PCL-5 スコア
除外基準
以下の除外基準の 1 つ以上が当てはまる場合、参加者は研究への参加から除外されます。
- インデックス外傷は16歳以前に発生しました
- 開放性頭蓋骨損傷の病歴
-以下を含むがこれらに限定されない神経障害の病歴：
- 発作性疾患
- 頭蓋内圧の上昇に関連する可能性が高い状態
- 空間占有脳病変
- 脳血管障害の病歴
- 脳動脈瘤の病歴
- EEG記録中の発作のリスクを示すEEG異常、すなわち、異常な局所的または一般的な減速、または発作時のスパイク
- スクリーニング時にEEG固有のアルファ周波数を計算できない
- -スクリーニング訪問前の3か月以内の介入研究プロトコルへの参加
- -あらゆるタイプのECT、rTMS、またはMeRT治療の履歴
- -スクリーニング訪問から30日以内に抗精神病薬で治療された
- -スクリーニング訪問から30日以内にベンゾジアゼピンまたは抗けいれん薬で治療された
- -制限された併用薬（すなわち、NDRI、SSRI、SNRI、またはQBDZ）による現在の治療 スクリーニング訪問時の過去60日間安定していない
- 頭蓋内インプラント (例: 動脈瘤クリップ、シャント、刺激装置、人工内耳、ステント、または電極) または口を除く頭部内または頭部上のその他の金属製物体で、安全に取り外すことができないもの
- 頭部内または頭部外のものを含む、埋め込み型または取り外しが安全でない生体医療機器で、刺激装置の磁場の影響を受ける可能性があるもの (例: 心臓ペースメーカー、除細動器 (ICD)、または投薬装置)
- -制御されていない甲状腺障害、肝臓、心臓、肺および腎臓の機能不全、または慢性的な過度のアルコール消費を含むがこれらに限定されない、臨床的に重要な医学的疾患または状態。試験結果の解釈
- -妊娠中、または女性が効果的な避妊を使用することを望まない 試験の過程で
- -スクリーニング訪問後80日以内に、その地域から離れることを計画している、またはその地域から不在になることを知っている（包括的）
- 治験責任医師の判断により、参加者が治験を完了することを妨げ、治験結果を解釈不能にする可能性がある、治験治療、データ収集スケジュール、または治験手順、または治験責任医師の判断で英語でのコミュニケーションができないことを含む何らかの状態を順守したくない、または順守することができない、または、除外基準に記載されていない、参加者または研究担当者に対する容認できない安全上のリスクを表す。
- -統合失調症または双極性障害、または治験責任医師の判断で参加者に潜在的な安全上のリスクをもたらす可能性のある他の精神障害を含むがこれらに限定されない、臨床的に重要な精神病理学、または試験結果の解釈を制限する
- 自殺や他人への暴力のリスクが高まる
- -現在の精神療法的治療は、試験全体で継続すると予想され、スクリーニング訪問時の過去60日間に開始されました
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：アクティブMeRT治療
積極的な治療は、1 分間に 6 秒、1 日 30 分間、週 5 日、5 週間で構成されます。
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各参加者の EEG 固有アルファ周波数 (IAF) に合わせて特別に調整された、磁気 EEG/ECG 共鳴療法 (MeRT) 治療として知られる、パーソナライズされたバイオメトリクスに基づくプロトコル。
rTMS は、参加者の IAF で適用されます。
他の名前：
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偽コンパレータ：シャムMeRT治療
偽治療は、1 分間に 6 秒、1 日 30 分間、週 5 日、5 週間で構成されます。
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rTMS コイルは磁気刺激を発しません。
他の名前：
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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 |
|---|---|---|
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PTSD症状の変化
時間枠：5週間
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PTSD チェックリスト 5 (PCL-5) によって測定される PTSD 症状の変化。
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5週間
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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 |
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PPCSの変化
時間枠：5週間
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TBI 後の PPCS を有する参加者のサブセットにおける Rivermead 脳震盪後症状アンケート (RPQ-16) の合計重症度スコアの減少によって測定される持続性脳震盪後症状の変化。
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5週間
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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安全性の結果 - 事件と有害事象の種類
時間枠：約3か月
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有害事象の数と種類（AES）および深刻な有害事象（SAE）
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約3か月
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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。
スポンサー
捜査官
- 主任研究者：Kenneth Ramos, MD,PhD、Texas A&M University
- スタディチェア：Adele Gilpin, PhD,JD、GilpinPhillips BIOMED, LLC
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。
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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 (実際)
2022年4月4日
一次修了 (実際)
2025年9月18日
研究の完了 (実際)
2025年11月4日
試験登録日
最初に提出
2016年11月10日
QC基準を満たした最初の提出物
2016年12月8日
最初の投稿 (推定)
2016年12月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年1月15日
QC基準を満たした最後の更新が送信されました
2026年1月14日
最終確認日
2026年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MeRT-005-B
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
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