Pilot Study to Investigate Brain Targets for Neuromodulation in Obsessive-compulsive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Symptom Intensity through VAS score
研究概览
简要总结
The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Participants must be enrolled in the IRB #853085 study
- •The inclusion criteria for the IRB #853085 study, which are also included in this trial are:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Adults aged 18-60 years old
- •Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
- •Presence of obsessions, compulsions, or both time-consuming obsessions and compulsions that take more than one hour a day or cause significant distress or impairment in social, occupation, or other important areas of functioning Obsessive-compulsive symptoms that are not attributable to the physiological effects of a substance (e.g., a drug of abuse, a medication) or another medical condition
- •Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 Severe OCD symptoms, as defined by Y-BOCS I score of 28 or higher, within two weeks prior to enrollment
- •Compulsions need to involve movement of the hands and/or arms so that the sleeve is able to detect participant's actions (cannot be solely mental or verbal compulsions)
- •Ability to understand procedure-related instructions and to complete study assessments in English, and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule, evaluations, etc.), in the opinion of the Principal Investigator
- •Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 8 Willingness and ability to provide informed consent, in the opinion of the Principal Investigator
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unable to undergo MRI scan
- •Presence of metallic implants or devices or tattoos
- •Claustrophobia or severe anxiety
- •Inability to remain still for duration of scan
- •Inability to fit and wear the ATTN201 device for the entire
- •Exclusion criteria for IRB study #853085 include:
- •Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the integrity of the study data
- •Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
- •Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the duration of the study or may impact, compromise, or affect the integrity of the data or results of the study.
- •Have a previous injury or surgery which could affect the nerve distribution
- •Have nerve damage (neuropathy)
- •Have a diagnosed neuromuscular disorder
- •Have a pacemaker
- •Have a history of skin allergies, psoriasis eczema, dermatitis, or other skin inflammation conditions
- •Compulsions cannot be completely mental or verbal actions, such as repeating words, counting objects, or performing mental rituals, and cannot involve only facial muscles/actions such as blinking or staring
结局指标
主要结局
Change in Symptom Intensity through VAS score
时间窗: From the first visit (Visit 1) through the final visit (Visit 10), approximately 6 weeks.
This outcome evaluates the change in symptom intensity using Visual Analog Scales (VAS) scores. VAS include questions regarding urges to compulse/resist compulsions and subjective units of distress (SUDs), measure the intensity of a patient's impulse to carry out or control and inhibit these compulsions, and the amount of distress they feel, and are on a scale between 0-100, where higher scores signify greater symptom severity.
Changes in Imaging between Pre- and Post-Intervention
时间窗: Before the first visit (Visit 1) and after the final visit (Visit 10), approximately 6 weeks
This outcome measure evaluates safety and efficacy through neuroimaging conducted prior to and following the intervention. These measures are intended to assess potential effects and target engagement associated with LIFU. Efficacy measures will include changes in MRI-derived metrics (e.g., functional connectivity and/or regional activation in predefined regions of interest associated with the stimulation target). Safety is assessed by the presence of new or worsening structural abnormalities, including edema, hemorrhage, or tissue injury.
Incidence of Adverse Events Assesed by Symptom Checklist
时间窗: Immediately after each intervention session and up to 24 hours post-intervention, assessed across the intervention period (Visits 6-9).
This outcome measure evaluates the incidence and severity of adverse events using a structured symptomatic checklist survey administered throughout the study period. The checklist captures the presence, frequency, and severity of potential adverse symptoms. Adverse events will be categorized by type, relatedness, and severity.
次要结局
- Physiological Changes Measured by EMG(Baseline through end of intervention period (Visits 2-9), with EMG data collected at every in-person visit, approximately 4 weeks.)
- Change in Y-BOCS score after sonication(From the first baseline visit (Visit 1) through the final visit (Visit 10).)
- Change in Acceleration Measured by IMU(Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.)
- Change in Angular Velocity Measured by IMU(Baseline through end of intervention period (Visits 2-9), with IMU data collected at every in-person visit, approximately 4 weeks.)
- Change in Heart Rate Assessed by Photoplethysmography (PPG)(Baseline through end of intervention period (Visits 2-9), with PPG data collected at every in-person visit, approximately 6 weeks.)
研究者
Katherine Scangos
Associate Professor CE of Psychiatry
University of Pennsylvania