治験レーダーAI | ||
|---|---|---|
治験 NCT06127342（対象：PTSD）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Exercise and Emotional Learning in Posttraumatic Stress Disorder
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06127342 は 介入研究 臨床試験 で、PTSD に関するものです。現在は 募集中 で、2024年5月13日 から開始しています。100 名の参加者 の募集が計画されています。この治験は Christal L Badour によって主催され、2026年11月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月3日 です。
概要
The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.
詳細説明
The proposed project would build on our published pilot data and animal models to demonstrate that moderate intensity physical exercise delivered after exposure therapy engages fear circuitry and enhances the consolidation of therapeutic safety learning, thereby enabling enhanced symptom reduction for PTSD. Adults with PTSD related to interpersonal violence (IPV) exposure would complete an initial session of imaginal exposure to traumatic memory cues adapted for an MRI setting. This would be followed by 30-mins of moderate intensity exercise or low intensity exercise control. Participants would return 24-hrs later to complete a second session of imaginal exposure with MRI.
公式タイトル
Exercise and Emotional Learning in Posttraumatic Stress Disorder
疾患／病気
PTSDその他の研究識別子
NCT番号
開始日
2024-05-13
最終更新日
2025-09-03
終了予定日
2026-11-30
目標参加者数
100
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Interpersonal Violence
Exercise
Exercise
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Moderate Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Moderate-Intensity Exercise (30-min at 70-75% max HR with 5-min warm-up and 5-min cool-down at 40-50% max HR), on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | 中強度運動 Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 5 minutes, then slowly cycle on a stationary bike for 30 minutes, then cycle on the stationary bike at a slow speed for 5 minutes. |
実薬対照薬Low Intensity Exercise Visit 1: Participants will complete study screening, PTSD assessments, and provide written narrative for a traumatic event and a neutral control event.
Visit 2: Participants will complete baseline structural MRI scans before completing 8 trials of imaginal exposure - 4 neutral then 4 trauma narratives - with psychophysiological and fMRI measurement. Following completion of the imaginal exposure task, the participant will perform Low-Intensity Exercise (control; 40-mins at 40-50% max HR),on a stationary bike.
Visit 3: Participants will complete the same imaginal exposure with measurement of psychophysiology, fMRI, and subjective emotional responding. | Low Intensity Exercise Participants will wear a heartrate monitor and cycle on a stationary bike at a slow speed for 40 minutes. |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in participant subjective emotional ratings | Participant anxiety will be measured at baseline and after each imagery trial using a 10-point Likert-type scale with higher scores indicative of more subjective anxiety. | 24 hours |
Change in Heart Rate | Participant heart rate will be measured at baseline and after each imagery trial using a Biopac MP160 system | 24 hours |
Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response | Blood Oxygen Level-Dependent (BOLD) imaging will be measured during each imagery trial | 48 hours |
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
- Adults with PTSD related to interpersonal violence
- Active or recent (within the last 3 months) severe substance use disorder(s)
- Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes
- Significant developmental disabilities
- Current daily benzodiazepine or stimulant use with inability to abstain for study sessions
- Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)
- Medical condition(s) that prohibit exercise
- History of traumatic brain injury (TBI) with loss of consciousness > 30 mins
- Magnetic resonance imaging (MRI) contraindication(s)
- Positive pregnancy test
- History of seizure disorder
- Spontaneous seizure(s) within the last 3 months
Christal L Badour- University of Texas at Austin
- National Institute of Mental Health (NIMH)
責任者
Christal L Badour, 治験依頼者・主任研究者, Associate Professor, University of Kentucky
試験中央連絡先
連絡先: Christal G Badour, PhD, 859-323-3817, [email protected]
2 1カ国の場所
Kentucky
University of Kentucky, Lexington, Kentucky, 40506, United States
Thomas G Adams, PhD, 連絡先, [email protected]
募集中
Texas
University of Texas, Austin, Texas, 78712, United States
Josh Cisler, PhD, 連絡先, 512-495-5162, [email protected]
募集中