Assessment of Safety and Feasibility of Focused Ultrasound Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Treatment-Resistant Depression
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and initial effectiveness of Magnetic Resonance-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH) device in patients with treatment-resistant depression. This is a prospective, single-arm, non-randomized study.
Participants will:
- Undergo two focused ultrasound treatment sessions targeting nodes of the cortical-striatal-thalamic circuit (CSTC) , spaced four weeks apart.
- Return for follow-up visits at 24 hours, 2 weeks, and 4 weeks after each treatment session, during which clinical scales and imaging assessments will be conducted to monitor safety and clinical effects.
详细描述
A total of 20 participants with treatment-resistant depression will be enrolled and treated in this study. Participants will be recruited through local psychiatric practices, referrals from participating institutions, and external referrals, including both physician and self-referrals.
Eligibility will be assessed during a dedicated screening appointment conducted by the study coordinator in collaboration with a study-affiliated physician. The anticipated enrollment period is approximately two years, beginning from the date of first patient enrollment to the enrollment of the final participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deemed to have the capacity to provide informed consent.
- •Aged between 18 and 65 years.
- •Diagnosis of major depressive disorder (MDD) according to DSM-5 criteria.
- •Total score >20 on the Hamilton Depression Rating Scale (HAMD-17).
- •On a stable regimen of psychiatric medications for at least 30 days prior to enrollment.
- •Documented previous trial of at least two first-line antidepressant agents at adequate dose and duration, as assessed by two psychiatrists.
- •Documented previous trial of cognitive behavioral therapy (CBT) or psychotherapy for MDD, sustained for at least 6 weeks.
排除标准
- •Pregnant or intending to become pregnant during the study period.
- •Diagnosis of a substance use disorder (excluding cannabis or nicotine) of moderate severity or greater, or when the substance is the primary focus of treatment, based on DSM-5 criteria.
- •Known active seizure disorder, significant head injury with an imaging-verified lesion
- •Unstable medical illness.
- •Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker)
- •Inability to reliably attend required screening, treatment, or follow-up appointments.
- •Severe claustrophobia, as identified by the participant, that would prevent completion of MRI procedures.
研究组 & 干预措施
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.
干预措施: Next Generation Dome Helmet (NGDH) (Device)
结局指标
主要结局
Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Treatment-Resistant Depression
时间窗: Assessments will be conducted at the baseline visit, 24 hours after the first treatment, 2 weeks after the first treatment, 24 hours after the second treatment, and at 2 and 4 weeks following the second treatment.
Assessment of the frequency and severity of adverse events associated with focused ultrasound neuromodulation in patients with treatment-resistant depression using the Next Generation Dome Helmet device. Adverse events, including procedure-related complications and neurological events, will be documented and assessed throughout the study period.
次要结局
- Clinical Efficacy - Change in Depressive Symptoms measured by Hamilton Depression Rating Scale (HAMD-17)(Assessed at 2 weeks after first treatment and 2 and 4 weeks after second treatment.)
研究者
Dr. Nir Lipsman
Principal Investigator
Sunnybrook Health Sciences Centre