Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
2026年7月10日 更新者：Dr. Nir Lipsman、Sunnybrook Health Sciences Centre
Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
This study evaluates the safety, feasibility, and preliminary efficacy of focused ultrasound (FUS) neuromodulation delivered using the Next Generation Dome Helmet (NGDH) in participants with treatment-refractory obsessive-compulsive disorder (OCD).
Participants will undergo two study sessions, four weeks apart, involving active FUS neuromodulation targeting nodes of the cortico-striato-thalamo-cortical (CTSC) circuit.
Outcomes include adverse events, changes in OCD symptom severity, and quality of life.
調査の概要
詳細な説明
This study is designed as a prospective, single arm, nonrandomized study aiming to evaluate safety and tolerability of transcranial focused ultrasound neuromodulation targeting CTSC circuit nodes (including VC/VS, STN, ACC, OFC, and caudate nucleus).
Twenty participants with treatment-refractory OCD will be enrolled. Each participant will receive two treatment sessions (4 weeks apart)
研究の種類
介入
入学 (推定)
20
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。
研究連絡先
- 名前：Anusha Baskaran, PhD
- 電話番号：61650 416-480-6100
- メール：anusha.baskaran@sunnybrook.ca
研究連絡先のバックアップ
- 名前：Nir Lipsman, MD, PHD, FRCSC, FAANS
- 電話番号：(416)-480-6954
- メール：Nir.Lipsman@sunnybrook.ca
研究場所
-
-
Ontario
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Toronto、Ontario、カナダ、M4N 3M5
- 募集
- Sunnybrook Health Sciences Centre
-
コンタクト：
- Anusha Baskaran, PhD
- 電話番号：61650 416-480-6100
- メール：anusha.baskaran@sunnybrook.ca
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Must be deemed to have the capacity to provide informed consent.
- Age 18 to 85 years.
- Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria.
- Yale-Brown Obsessive Compulsive Scale total score greater than 22.
- If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study.
- Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists.
- Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks.
Exclusion Criteria:
- Pregnant or intending to become pregnant during the study.
- Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria.
- Known active seizure disorder or significant head injury with an imaging-confirmed lesion.
- Unstable medical illness.
- Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device.
- Unable to reliably attend the required screening, treatment, and follow-up visits.
- Severe claustrophobia that would prevent MRI scanning.
- History of a bleeding disorder or coagulopathy.
Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including:
- Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment
- Non-vitamin K oral anticoagulants within 72 hours of treatment
- Heparin-derived compounds within 48 hours of treatment
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Focused Ultrasound Neuromodulation
Focused Ultrasound Neuromodulation: Participants will receive two sessions of Magnetic Resonance-guided focused ultrasound neuromodulation targeting regions within the cortical-striatal-thalamic circuit (CSTC) implicated in treatment-resistant depression.
Treatments will be spaced four weeks apart.
All participants will receive the same intervention and will be followed for 4 weeks post-treatment to evaluate clinical outcomes, adverse events, and depression symptoms.
|
参加者は、次世代のドームヘルメットデバイスを使用して、4週間間隔で間隔を置いた磁気共鳴誘導焦点の焦点を絞った超音波神経調節の2つのセッションを受け取ります。
治療は、高度なMRIスキャンによって特定されたCSTC回路内の領域を標的とします。
各セッションには、治療前の評価、深部脳構造の正確な超音波処理、リアルタイムの安全性監視、および治療後のイメージングが含まれます。
|
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 |
|---|---|---|
|
Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
時間枠：Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-refractory obsessive-compulsive disorder.
Adverse events, including procedure-related complications and neurological events, will be documented and assessed.
|
Assessments will be conducted at the baseline visit; on the day of each of the two treatments; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
Evaluate the effectiveness of FUS Neuromodulation in reducing obsessive-compulsive symptom severity using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
The Y-BOCS is a clinician-administered scale assessing the severity of obsessive-compulsive symptoms.
Total scores range from 0 to 40, with higher scores indicating greater symptom severity (0-7 subclinical, 8-15 mild, 16-23 moderate, 24-31 severe, and 32-40 extreme).
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
The Q-LES-Q is a self-report measure assessing quality of life across multiple domains.
Total scores are typically transformed into a percentage of the maximum possible score, with higher percentages indicating greater life satisfaction and functioning.
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
The Obsessive Compulsive Inventory is a self-report measure used to assess obsessive-compulsive symptoms.
Higher scores indicate greater symptom severity.
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
The Beck Anxiety Inventory (BAI) is a 21-item self-report scale assessing the severity of anxiety symptoms.
Total scores range from 0 to 63, with higher scores indicating greater anxiety severity (0-7 minimal, 8-15 mild, 16-25 moderate, and 26-63 severe anxiety).
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
The GAD-7 is a 7-item self-report questionnaire used to assess generalized anxiety symptoms.
Total scores range from 0 to 21, with higher scores indicating greater anxiety severity.
Scores of 5, 10, and 15 represent commonly used thresholds for mild, moderate, and severe anxiety, respectively.
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Patient-Reported Outcomes Using Likert Scales (1-9)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
A brief set of 1-9 Likert scales will be used to assess patient-reported symptoms and subjective experiences.
Scores range from 1 to 9, with higher scores indicating greater symptom severity or impact.
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
|
Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
時間枠：Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
The HAMD-17 is a clinician-administered scale used to assess the severity of depressive symptoms.
Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity.
Change from baseline will be evaluated at each assessment time point.
|
Assessments will be conducted at baseline; 24 hours after each treatment; at 1 and 2 weeks after each treatment; and 4 weeks after the second treatment.
|
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。
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)
2025年9月23日
一次修了 (推定)
2027年9月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年7月10日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年7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7月10日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 6791
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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
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いいえ
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いいえ
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