経脊髄刺激と SCI のための自発運動トレーニング
脊髄損傷における自発運動の利点を増強するための高周波経脊髄刺激によるプライミング
調査の概要
状態
詳細な説明
脊髄損傷 (SCI) は、立ったり歩いたりする能力を大幅に損ない、日常生活活動を著しく損ないます。 これらの赤字は自発運動トレーニングによって部分的に改善されますが、複数のトレーニングセッションの後でも、異常な筋肉活動と協調は依然として持続します. したがって、自発運動トレーニングだけでは、脳、脊髄、局所回路をつなぐシナプスを強化するために必要なニューロンの可塑性を完全に最適化することはできません。 そのため、脊髄運動ネットワークのニューロモジュレーションを効果的に促進し、損傷したヒト脊髄の神経接続を物理的リハビリテーションと組み合わせて強化する治療介入が大いに必要とされています。 経皮的脊髄(経脊髄)刺激は、神経系を相乗的に「プライミング」して自発運動訓練によりよく反応する方法として提案されています。 経脊髄刺激は、複数の脊髄セグメントにわたって運動ニューロンの興奮性を変化させます。これは、下降および局所入力が機能するための前提条件です。 重要なことに、経脊髄刺激と自発運動訓練による同時治療が、SCI 後の運動回復を最大化するかどうかは不明です。 この臨床試験の目的は、高周波 (30 Hz) 経脊髄刺激を使用して自発運動訓練を開始し、最終的に慢性不完全 SCI (iSCI) 患者の立位、歩行、および全体的な機能を改善することです。 iSCI を持つ 45 人の個人は、高周波経脊髄刺激で準備された体重サポート ステップ トレーニングの 40 セッションを受けます。 参加者は、立っている間 (リアルまたは偽) または仰臥時 (リアル) に経脊髄刺激を受けるように無作為化されます。 目的 1 は、脚から記録された運動誘発電位によって示されるように、SCI における高周波経脊髄刺激によるプライミング自発運動トレーニングが皮質運動神経結合強度をどのように変化させるかを評価します。
目的 2 は、iSCI における高周波経脊髄刺激による自発運動のプライミングが、脊髄神経回路の再編成と適切な関与にどのように影響するかを評価します。 最後に、目標 3 は、活動に基づく運動機能、立ったり歩いたりする能力、生活の質を評価します。 これらの結果は、トニック高周波経脊髄刺激が皮質運動神経結合を強化し、姿勢依存性皮質脊髄神経可塑性を通じて脊髄回路組織を改善するという概念を支持します。 この機構的臨床試験から得られた情報は、臨床診療に大きな影響を与えることが期待されています。 これは、実際の臨床環境では、非侵襲的な経脊髄刺激が侵襲的な硬膜外刺激よりも簡単かつ広く実施できるためです。
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Maria Knikou, PT, PhD
- 電話番号:17189823316
- メール:Maria.Knikou@csi.cuny.edu
研究連絡先のバックアップ
- 名前:Noam Y. Harel, MD, PhD
- 電話番号:1742 718-584-9000
- メール:noam.harel@mountsinai.org
研究場所
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New York
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Bronx、New York、アメリカ、10468
- 募集
- Veterans Affairs Medical Center
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コンタクト:
- Noam Y. Harel, MD, PhD
- 電話番号:1742 718-584-9000
- メール:noam.harel@mountsinai.org
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コンタクト:
- Gregory Mendez, BS
- 電話番号:3107 718-584-9000
- メール:gregory.mendez1@va.gov
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Staten Island、New York、アメリカ、10314
- 募集
- Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory
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コンタクト:
- Maria Knikou, PT, PhD
- 電話番号:718-982-3316
- メール:maria.knikou@csi.cuny.edu
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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
説明
包含基準:
- -研究期間中のすべての研究手順と利用可能性を遵守する意欲。
- 同意書を理解し、同意書に署名する能力。
- 18~70歳の男性または女性。
- 病歴から明らかなように、一般的な健康状態は良好です。
- 運動不完全SCI(AIS C-D)と診断されました。
- 股関節(近位大腿骨)の骨密度 Tスコア
- 胸部 (T) 10 より上の病変は、下部運動ニューロン病変がないことを確認します。
- ヒラメ筋H反射を誘発できる腱反射の存在。
- 皮質脊髄および脊髄の興奮性は足首の角度に基づいているため、受動的または能動的な足首の動きを妨げる恒久的な足首関節拘縮の欠如。 Lokomat の足首ストラップには、柔軟な足首関節も必要です。
- -外傷、血管、または整形外科の病理による初回のSCIの診断。
- -SCI後の6か月以上の時間。
- 心肺疾患や認知障害のない安定した病状。
除外基準:
- 棘上病変。
- 末梢神経系の重大な神経障害。
- 脊椎または脊髄の重大な変性神経障害。
- AIS A または B。
- 褥瘡の存在。
- 高度な尿路感染症。
- 脊椎または脊髄の腫瘍性または血管障害。
- 進行中の調査研究または新しいリハビリテーション プログラムへの参加。
- 胎児への胸腰部刺激の危険性が不明なため、妊婦または妊娠の可能性がある、または妊娠している可能性がある女性は参加から除外されます。
- 人工内耳、ペースメーカー、埋め込み式注入装置、および/またはあらゆる種類および目的の埋め込み式刺激装置を装着している人は、刺激による機能不全を避けるために除外されます。
- 発作歴のある人。
- 発作の可能性を高める病状。
- 発作の閾値を変える可能性のある薬。
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
- 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: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 |
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実験的:立っている間に実際の経脊髄刺激を行い、その後に自発運動トレーニングを行います
安全性を確保するために、立位フレームまたはロコマットで必要に応じて体重サポート (BWS) を使用して、立位中に胸腰部の経脊髄緊張刺激を 30 Hz の周波数で提供します。
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脊髄損傷のある 15 人が、立っている間に 30 分間の非侵襲的な高周波数 (30 Hz など) の経皮的経脊髄刺激を毎日 40 回受け、続いて 30 分間のアシスト付きステッピング ロボット歩行トレーニングを受けます。
トレーニングの前後に、標準化された臨床および神経生理学的テストを使用して、感覚運動機能の回復を評価します。
他の名前:
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実験的:仰臥位で実際の経脊髄刺激を行い、運動訓練を行う
仰臥位で 30 Hz の周波数で経脊髄強直刺激を与えます。
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脊髄損傷の 15 人が、治療台に仰向けに寝た状態で 30 分間の非侵襲的な高周波 (30 Hz など) の経皮的経脊髄刺激を毎日 40 セッション受け、続いて 30 分間のアシスト付きステッピング ロボット歩行トレーニングを受けます。
トレーニングの前後に、標準化された臨床および神経生理学的テストを使用して、感覚運動機能の回復を評価します。
他の名前:
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偽コンパレータ:歩行訓練に続いて立っている間に配信される偽の経脊髄刺激
1 つの偽のグループは、感覚がない強度で立っている間に経脊髄刺激を受けます。
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脊髄損傷者 15 人は、感覚がない強度で立っている間に 30 分間の疑似経脊髄刺激を毎日 40 セッション受け、その後 30 分間のロボット歩行トレーニングを受けます。
トレーニングの前後に、標準化された臨床および神経生理学的テストを使用して、感覚運動機能の回復を評価します。
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 |
---|---|---|
脊髄神経回路網の可塑性
時間枠:4年
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安静時およびロボット支援ステッピング中の両方で、後脛骨神経および総腓骨神経刺激後のヒラメ筋 H 反射の振幅変調を記録することにより、介入による興奮性および抑制性脊髄反射の興奮性の変化を調べる神経生理学的評価。
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4年
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皮質脊髄ネットワークの可塑性
時間枠:4年
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安静時およびロボット支援ステッピング中の単一パルス経頭蓋磁気刺激 (TMS) に対する応答を記録することにより、介入による皮質脊髄興奮性の変化を評価する神経生理学的測定。
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4年
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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 |
---|---|---|
歩行機能
時間枠:4年
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2分間のウォーキングと10メートルのタイムテストに変更。
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4年
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バランス
時間枠:4年
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BESTtest 臨床評価の変更。
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4年
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自律神経機能
時間枠:4年
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参加者が腸、膀胱、および性機能の変化を認識したかを評価するアンケート
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4年
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協力者と研究者
捜査官
- 主任研究者:Noam Y. Harel, MD, PhD、Bronx Veterans Medical Research Foundation
- 主任研究者:Maria Knikou, PT, PhD、Research Foundation of the City University of New York
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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。
脊髄損傷の臨床試験
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Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud Centre, Lisbon,...積極的、募集していないメラノーマ | 肉腫 | 卵巣がん | 骨 | 軟部組織 | リンパ節 | CNS-Spinal CD/MEMBR、NOSアメリカ, イタリア, ポルトガル