Transcranial Ultrasonic Stimulation in Treatment-resistant Depression: an Open-label Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint
研究概览
简要总结
The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years,
- •Diagnosis of major depressive episode (MDE) as part of major depressive disorder as defined by DSM-5 criteria
- •Severe MDE (HDRS-17> 20)
- •Drug resistance to at least two well-conducted antidepressant treatment lines
- •With stable antidepressant treatment for at least 4 weeks before inclusion
- •Benefiting from a social security scheme
- •Having given their consent to participate
排除标准
- •Psychiatric history other than a mood disorder
- •Neurological history, including epilepsy and intracerebral calcifications
- •History of substance use disorder other than tobacco
- •Contraindication to brain MRI (pacemaker, neurostimulator, injury from metallic shine, …)
- •Compulsory psychiatric care
- •Protected adults, people under legal safeguard
- •Pregnant or breastfeeding woman
- •Women of childbearing age who do not have a negative pregnancy test and are not using contraception
研究组 & 干预措施
TUS - 5 min sessions, 5% duty cycle, 5 sessions/day (n=5)
Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 5 minutes at a 5% duty cycle, delivered 5 times per day for 5 days (25 sessions total).
干预措施: Transcranial Ultrasonic Stimulation prototype (Device)
TUS - 40 min sessions, 5% duty cycle, 2 sessions/day (n=7)
Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle, delivered 2 times per day for 5 days (10 sessions total).
干预措施: Transcranial Ultrasonic Stimulation prototype (Device)
TUS - 40 min sessions, 1% duty cycle, increased acoustic power, 2 sessions/day (n=10)
Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 1% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total).
干预措施: Transcranial Ultrasonic Stimulation prototype (Device)
TUS - 40 min sessions, 5% duty cycle, increased acoustic power, 2 sessions/day (n=10)
Low-intensity transcranial focused ultrasound stimulation of deep brain target, using a personalized acoustic lens to correct the aberrations induced by the skull. Sessions of 40 minutes at a 5% duty cycle with increased acoustic power, delivered 2 times per day for 5 days (10 sessions total).
干预措施: Transcranial Ultrasonic Stimulation prototype (Device)
结局指标
主要结局
Percent change in the Montgomery-Åsberg Depression Scale (MADRS) score from baseline to primary endpoint
时间窗: Pre-treatment and Day 5 from start of intervention
MADRS is a ten item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
次要结局
- Percent change in the Hamilton Rating Scale for Depression (HDRS-17)(Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention)
- Percent change in the Hamilton Rating Scale for Depression (HDRS-6)(Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention)
- Assess the changes in functional connectivity of sgACC after TUS(Pre-treatment and Day 7 from start of intervention)
- Percent change in the Inventory of Depressive Symptomatology (IDC-C)(Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention)
- Incidence of serious adverse reactions according to the Common Terminology Criteria for Adverse Events (CTCAE) scale(Day 1 to Day 35 from start of intervention)
- Percent change in the Montgomery-Åsberg Depression Scale (MADRS)(Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention)
- Percent change in the Quick Inventory of Depressive Symptomatology (QIDS-SR)(Pre-treatment and Day 1, Day 2, Day 3, Day 4, Day 5, Day 12 ± 2, Day 19 ± 2, Day 26 ± 2, Day 33 ± 2 from start of intervention)