The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with refractory depression and anxiety.
详细描述
The present study is designed as an open label study of patients with refractory depression and anxiety to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with refractory depression, the target will be the subgenual cingulate (Brodmann's area 25) through a trans temporal scalp window. For patients with anxiety, the target will be the amygdala. Targeting will include reference to scalp fiducials based on the obtained MRI and Doppler waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe.
On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the subgenual cingulate or amygdala, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.
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 93 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Depression:
- •Diagnosis of Major Depressive Disorder
- •Score greater than 13 on the Beck Depression Inventory
- •Failure to remit with 3 antidepressants
- •At least 18 years of age
- •Inclusion Criteria for Anxiety:
- •Diagnosis of Generalized or Acute Anxiety Disorder
- •Score greater than 15 on the Beck Anxiety Inventory
- •Failure to remit with 3 anxiolytics
- •At least 18 years of age
排除标准
- •for Depression & Anxiety:
- •Cognitive decline clearly related to an acute illness
- •Subjects unable to give informed consent
- •Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
- •Recent surgery or dental work within 3 months of the scheduled procedure.
- •Pregnancy, women who may become pregnant or are breastfeeding
- •Advanced terminal illness
- •Any active cancer or chemotherapy
- •Any other neoplastic illness or illness characterized by neovascularity
- •Macular degeneration
- •Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
- •Advanced kidney, pulmonary, cardiac or liver failure
研究组 & 干预措施
Treatment
All patients enrolled will receive transcranial focused ultrasound. Target location is dependent on patient condition.
干预措施: Focused Transcranial Ultrasound (Device)
结局指标
主要结局
Beck Depression Inventory
时间窗: Baseline prior to ultrasound administration (
\[Primary for patients enrolled for depression\] The BDI-II is a 21-question multiple-choice self-report inventory. Each question involves four possible responses, ranging in intensity from "0" (this item does not apply) to "3" (this item applies severely). The test is scored as the sum of all of the response values; this number is used to determine the severity of depressive symptoms. A score of 0 to 3 is possible for each question with a maximum total score of 63 points. The standard cutoff scores are as follows: 0-13 total points = minimal depression; 14-19 total points = mild depression; 20-28 total points = moderate depression; and 29-63 total points = severe depression. A reduction in the total score by at least 30% is considered to be clinically significant.
Hamilton Anxiety Rating Scale
时间窗: Baseline prior to ultrasound administration
\[Primary for patients enrolled for anxiety\] The HAM-A is an observer/rater scale consisting of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
次要结局
- Hamilton Anxiety Rating Scale(After final ultrasound (8 weeks from baseline))
- Patient Depression Questionnaire(After final ultrasound (8 weeks from baseline))
- Beck Anxiety Inventory(After final ultrasound (8 weeks from baseline))
- Beck Depression Inventory(After final ultrasound (8 weeks from baseline))
- Hamilton Depression Rating Scale(After final ultrasound (8 weeks from baseline))
- Beck Anxiety Inventory(Baseline prior to ultrasound administration)
- Hamilton Depression Rating Scale(Baseline prior to ultrasound administration)