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治験 NCT05566769 (OPTIS)（対象：視神経脊髄炎）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
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD (OPTIS)
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 NCT05566769 (OPTIS) は 介入研究 臨床試験 で、視神経脊髄炎 に関するものです。現在は 募集中 で、2023年11月3日 から開始しています。103 名の参加者 の募集が計画されています。この治験は Ad scientiam によって主催され、2026年9月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年4月10日 です。
概要
NMOSDCopilot is a digital tool developed for the self-assessment of Neuromyelitis Optica Spectrum Disorder symptoms that impact patients' functioning and quality of life. It has been co-designed with the help of patient advocacy groups, NMOSD patients and medical experts. It includes a smartphone-based application for patients, connected to a web portal developed for healthcare professionals (HCSPs). The patient application is composed of vision, walking, cognition, and dexterity e-active tests inspired by clinical standards, as well as e-questionnaires. The HCP web portal is a desktop-based software that allows HCPs to access the results generated via the patient application and facilitates remote monitoring of patients' symptoms.
The objectives of this study are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone versus the standard in-clinic testing, as well as to evaluate the safety of use of the tool, its usability, and satisfaction towards the patient application among NMOSD patients, and the HCP web dashboard among HCPs.
公式タイトル
Performance and Safety of a Digital Tool for Unsupervised Self-assessment of Neuromyelitis Optica Spectrum Disorder
疾患／病気
視神経脊髄炎その他の研究識別子
- OPTIS
NCT番号
開始日
2023-11-03
最終更新日
2025-04-10
終了予定日
2026-09
目標参加者数
103
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
NMO
NMOSD
Neuromyelitis optica
Neuromyelitis optica spectrum disorder
NMOSD
Neuromyelitis optica
Neuromyelitis optica spectrum disorder
主目的
その他
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的NMOSDCopilot Performance of digital tests and standard test in clinic at D0 and M6 Use of NMOSDCopilot at-home in between visits during 12 months | NMOSDCOPILOT Smartphone Application NMOSDCopilot includes active tests for walking, cognition, dexterity and vision, and e-questionnaires related to pain, fatigue, quality of life, bladder and bowel dysfunction, depression |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To compare results obtained with unsupervised at-home e-active tests and the corresponding supervised in-clinic standard tests, test to test | Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline | Standard tests results at Baseline versus e-active tests results at D0 + 7 days |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To assess reproducibility between in-clinic and at-home e-active tests | Pearson correlation coefficient (or Spearman's rank-order correlation depending on the data distribution) between e-active tests at day 7 versus standard tests at baseline and between and month 6 and month 6- 7days | Baseline, day 7, month 6 - 7 days, month 6 |
To assess test-retest reliability of at-home e-active tests | Intraclass correlation coefficient of e-active tests | Month 1, month 2, month 3, month 4, month 5 |
To compare results obtained with in-clinic e-active tests and in-clinic standard tests, test to test | Pearson's correlation coefficient of inc-clinic e-active tests and in-clinic standard tests | Baseline, month 6, month 12 |
To assess the adverse events related to of the mobile application use. | descriptive analysis of adverse events (AEs) related to the use of the application. | through study completion, 21 months |
To assess pain | Pain Visual Analogue Scale (0-100) higher score meaning a worse outcome | Month 3, month 6, month 12 |
To assess fatigue | Modified Fatigue Impact Scale 5 (0-20) higher score meaning a worse outcome | Month 3, month 6, month 12 |
To assess bladder control | Bladder Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 |
To assess bowel control | Bowel Control Scale (0-22) higher score meaning a worse outcome | Month 3, month 6, month 12 |
To assess depression | Patient Health Questionnaire-8 (0-12) higher score meaning a worse outcome | Month 3, month 6, month 12 |
To assess quality of life | p-value of multivariate analysis for non-parametric data | Baseline, month 6, month 12 |
To assess disability | Expanded Disability Status Scale (0-10), higher score meaning a worse outcome | Baseline, month 6, month 12 |
To assess satisfaction and user experience with the smartphone application and the web dashboard | Descriptive analysis of satisfaction and user experience questionnaires (System Usability Scale (1-100) higher score meaning a better outcome) | Through study completion, 21 months |
To assess at-home compliance and adherence to the patient application | Descriptive analysis of the mobile application's adherence data (number of completed questionnaires, number of sessions performed etc.). | Through study completion, 21 months |
To compare results obtained with at home MVT and in-clinic OCT-scan | The Pearson's correlation coefficient will be used to assess the relation between MVT e-active test at D0 +7 (home) versus standard OCT-scan test at D0 (in clinic). The minimum coefficient to reach is 0.65 to show that low contrast visual acuity measurement is associated with. RNF \& GCIP layer thickness | Through study completion, 21 months |
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- Aged over 18 years old
- NMOSD as defined by the 2015 international consensus diagnostic criteria (AQP4+ only)
- With NMOSD treatment (treatment must be unchanged since 6 months before enrollment, and 1 month for analgesics, antidepressants, neuroleptics)
- EDSS =< 7
- With no evidence of relapse in the past 3 months before enrollment
- Who have read the information sheet and signed the informed consent form
- Able to use a smartphone
- Owns a personal smartphone which version is above 13 for IOS and 8 for Android included
- Able to read language in which the mobile application is available and able to understand pictograms
- Evidence of neurologic, rheumatologic or psychiatric disorder other than NMOSD, including but not limited to major head trauma, seizures or systemic medical diseases that are likely to affect cognitive, upper limb or lower limb functioning
- Pregnant and nursing women
- Person under guardianship or curatorship
- Bedridden patients or patients with a daily activity of less than 2 hours per day
- Current drugs or/and alcohol abuse that could influence performance on the tests (clinician's judgment)
- Subject has participated in another clinical study within the previous 30 days of screening or is currently participating in another study that, in the opinion of the Investigator, might interfere with the participant's full participation in the study or confound the assessment of the participant or outcome of the study.
Ad scientiam試験中央連絡先
連絡先: Dr Levy, 617-726-7565, [email protected]
22 3カ国の場所
California
University of Southern California, Los Angeles, California, 90033, United States
Dr Lilyana Amezcua, 連絡先, 323 442-5710, [email protected]
Dr Amezcua, 研究責任者
募集中
University of California Davis Health, Sacramento, California, 95817, United States
Dr Apperson, 連絡先, 800 282 3284, [email protected]
Dr Apperson, 研究責任者
募集中
Florida
University of south Florida, Tampa, Florida, 33612, United States
John Ciotti, MD, 連絡先, 8133969478, [email protected]
Dr Ciotti, 研究責任者
募集中
Illinois
NorthShore University HealthSystem, Evanston, Illinois, 60201, United States
Afif Hentati, MD, 連絡先, +1 847-570-2570, [email protected]
Dr Hentati, 研究責任者
募集中
Maryland
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center), Baltimore, Maryland, 21287, United States
Elias S Sotirchos, 連絡先, 410-614-1522, [email protected]
Dr Sotirchos, 研究責任者
募集中
Massachusetts
Massachussets General Hospital, Boston, Massachusetts, 02114, United States
Michael Levy, MD, PhD, 連絡先, (617) 726-7565, [email protected]
Dr Levy, 研究責任者
募集中
Missouri
Washington University in St. Louis, Washington, Missouri, 63130, United States
Robert T Naismith, MD, 連絡先, 314-362-3293, [email protected]
Dr Naismith, 研究責任者
募集中
Nevada
CC Lou Ruvo Center for Brain Health, Las Vegas, Nevada, 89106, United States
Le Hua, MD, 連絡先, 7024836000, [email protected]
Dr Le Hua, 研究責任者
募集中
North Carolina
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27514, United States
Dr Dujmovic, 連絡先, 984 974-4401, [email protected]
Dr Dujmovic, 研究責任者
募集中
Oklahoma
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, 73104, United States
Gabriel Pardo, MD, 連絡先, (405) 271-6673, [email protected]
募集中
Hôpital Roger Salengro, Lille, 59037, France
Helene Zephir, Pr, 連絡先, 03 20 44 59 62, [email protected]
募集中
CHU Marseille - La Timone, Marseille, 13385, France
Dr Maarouf, 連絡先, 04.91.38.00.00, [email protected]
Dr Maarouf, 研究責任者
募集中
CHU de Montpellier, Montpellier, 34295, France
Pierre Labauge, Pr, 連絡先, 04 67 33 94 69, [email protected]
募集中
Hopital La Pitié Salpétrière, Paris, France
Elisabeth Maillart, Dr, 連絡先, 01 42 17 62 05, [email protected]
募集中
CHU Rouen, Rouen, 76038, France
実施中／登録終了
Hopital de Hautepierre, Strasbourg, 67000, France
完了
CHU Toulouse - Hôpital Purpan, Toulouse, 31059, France
Dr Ciron, 連絡先, +33 5 61 77 91 06, [email protected]
Dr Ciron, 研究責任者
募集中
Universitätsklinikum Carl Gustav Carus, Dresden, 01397, Germany
Dr Ziemssen, 連絡先, +49 (0) 351 458 7450, [email protected]
Dr Ziemssen, 研究責任者
Dr Inojosa, 副研究者
募集中
Universitätsklinik Essen, Essen, 45147, Germany
Dr Pul, 連絡先, +49 201 / 723- 82382, [email protected]
Dr Pul, 研究責任者
募集中
University Munich, Munich, 80336, Germany
Dr Havla, 連絡先, +49 89 4400 74781, [email protected]
Dr Havla, 研究責任者
Dr Kumpfel, 副研究者
Dr Gerdes, 副研究者
募集中
Hopital Rechts der Isar der Technischen Universitat Munchen, Munich, Germany
Achim Berthele, Dr, 連絡先, +49 89 41400, [email protected]
募集未定