The Effects of Repetitive Transcranial Magnetic Stimulation Prefrontal Target Location on Outcomes for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Percentage Change in Patient Health Questionnaire 9-Item Assessment Score
研究概览
简要总结
The purpose of this study is to examine the effects of different treatment locations using repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.
详细描述
Currently there is little standardization between rTMS treatment programs as to what is the best way to localize the left dorsolateral prefrontal cortex, which is the FDA-approved treatment location for clinical rTMS for major depressive disorder (MDD). Different targeting methods yield locations that can vary by up to a few centimeters. By comparing different treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and neuropsychological measures, this study would provide the opportunity to identify the optimal treatment targeting method when using rTMS for major depressive disorder in a clinical setting. This study will specifically be focusing on comparing the two most common targeting methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the F3 target location on the left prefrontal scalp as identified using the 10-20 EEG system nomenclature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder
- •Age between 18 and 90 years
- •rTMS is clinically indicated as determined by clinical rTMS physician team at University of Iowa
排除标准
- •rTMS contraindication such as implanted ferromagnetic material in the head or history of epilepsy with poorly controlled seizures
- •MRI exclusion criteria (if participating in MRI portion of study) including implanted device such as:
- •Pacemaker
- •Coronary Stent
- •Defibrillator
- •Neurostimulation
- •Or any of the following conditions:
- •Claustrophobia
- •Uncontrolled high blood pressure
- •Poorly controlled atrial fibrillation
- •Significant heart disease
- •Hemodynamic instability
- •Severe kidney disease
- •Pregnant, trying to become pregnant, or breast feeding
结局指标
主要结局
Percentage Change in Patient Health Questionnaire 9-Item Assessment Score
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Overall change in total Patient Health Questionnaire 9-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assessment measures depression severity at baseline. Total scores of 5, 10, 15, and 20 represent markers for mild, moderate, moderately severe, and severe depression, respectively. All 9 items are summed to compute a total score, ranging from 0-27. Higher scores indicate more severe self-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Percentage Change in Montgomery-Asberg Depression Rating Scale Score
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Overall change in total Montgomery-Asberg Depression Rating Scale score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This scale assesses depression severity at baseline. Scores of 8, 17, and 34 are cut-off points for mild, moderate, severe depression, respectively. This 10 item scale is summed to compute a total score, ranging from 0-60. Higher scores indicate more severe clinician-rated depressive symptoms. Negative change from baseline implies a decrease in depressive symptoms.
Percentage Change in General Anxiety Disorder 7-Item Assessment Score
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Overall change in total General Anxiety Disorder 7-Item Assessment score from pre to post-treatment assessment, comparing results of 2 active groups to assess for superiority of one treatment to the other. This assesses anxiety severity as baseline. Scores of 5, 10, and 15 are cut-off points for mild, moderate, and severe anxiety, respectively. All 7 items are summed to compute a total score, ranging from 0-21. Higher scores indicate more severe self-rated anxiety symptoms. Negative change from baseline implies a decrease in anxiety symptoms.
Response and Remission Rates on Patient Health Questionnaire 9-Item Assessment
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Comparison of the response rate (\>50% improvement) and remission rate (score \<5) for the Patient Health Questionnaire 9-Item Assessment between the 2 groups post-treatment.
Response and Remission Rates on Montgomery-Asberg Depression Rating Scale
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Comparison of the response rate (\>50% improvement) and remission rate (score \<10) for the MADRS between the 2 groups post-treatment.
Response Rates on General Anxiety Disorder 7-Item Assessment
时间窗: Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.
Comparison of the response rate (\>50% improvement) for the General Anxiety Disorder 7-Item Assessment between the 2 groups post-treatment.
次要结局
- Montreal Cognitive Assessment Score Changes(Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.)
- Emotion Measures(Pre-assessment will be obtained within approximately 1 week of starting rTMS. Post-assessment will be obtained immediately following completion of rTMS course, usually 4-6 weeks later.)
研究者
Nicholas Trapp
Physician-Associate and Neuromodulation Fellow
University of Iowa