Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment Refractory Obsessive Compulsive Disorder (OCD)
2026년 7월 10일 업데이트: 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.
연구 개요
상세 설명
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)
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Anusha Baskaran, PhD
- 전화번호: 61650 416-480-6100
- 이메일: anusha.baskaran@sunnybrook.ca
연구 연락처 백업
- 이름: Nir Lipsman, MD, PHD, FRCSC, FAANS
- 전화번호: (416)-480-6954
- 이메일: Nir.Lipsman@sunnybrook.ca
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4N 3M5
- 모병
- Sunnybrook Health Sciences Centre
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연락하다:
- Anusha Baskaran, PhD
- 전화번호: 61650 416-480-6100
- 이메일: anusha.baskaran@sunnybrook.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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참가자는 차세대 돔 헬멧 장치를 사용하여 4 주 간격으로 간격을 두는 자기 공명 유도 중심 초음파 신경 조절 세션을받습니다.
처리는 고급 MRI 스캔으로 식별 된 CSTC 회로 내 영역을 대상으로합니다.
각 세션에는 전처리 평가, 깊은 뇌 구조의 정확한 초음파 처리, 실시간 안전 모니터링 및 치료 후 영상이 포함됩니다.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and Feasibility of FUS Neuromodulation in Participants With Treatment-Refractory Obsessive-Compulsive Disorder
기간: 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.
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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.
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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.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Obsessive-Compulsive Symptom Severity Measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
기간: 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.
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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).
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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.
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Change in Quality of Life as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
기간: 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.
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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.
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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.
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Change in Obsessive-Compulsive Symptoms as Measured by the Obsessive Compulsive Inventory (OCI)
기간: 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.
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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.
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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.
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Change in Anxiety Symptoms as Measured by the Beck Anxiety Inventory (BAI)
기간: 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.
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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.
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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.
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Change in Anxiety Symptoms as Measured by the Generalized Anxiety Disorder-7 (GAD-7)
기간: 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.
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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.
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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.
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Change in Patient-Reported Outcomes Using Likert Scales (1-9)
기간: 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.
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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.
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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.
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Change in Depressive Symptoms as Measured by the 17-Item Hamilton Depression Rating Scale (HAMD-17)
기간: 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.
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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.
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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.
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 9월 23일
기본 완료 (추정된)
2027년 9월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 7월 10일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
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- 6791
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