Augmenting Repetitive Transcranial Magnetic Stimulation (rTMS) With Cognitive Control Training in Major Depressive Disorder (MDD)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Feasibility assessed by percentage of CCT sessions completed during rTMS
研究概览
简要总结
Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for MDD, but the overall effect sized of the treatment is equivalent to antidepressant pharmacotherapy, and responses are highly variable. Given that rTMS is usually given to patients who have failed pharmacotherapy, a more effective alternative is needed.
Therefore, this study will combine computerized cognitive training (CCT) during standard rTMS treatments and assess its feasibility, tolerability, and changes in cognitive control performance and depression symptoms.
Participants that agree to the study and meet eligibility will receive standard rTMS (generally 25-36 daily treatments) along with CCT (starting on day 5 of treatment until the pre-taper treatment). In addition, to CCT participants will be asked to complete assessments before and after treatment
详细描述
This project will also have a registry for participants that are approached to be in the clinical trial with the CCT but don't wish to be enrolled. Although the registry will be available for these participants, the information entered into this ClinicalTrials.gov registration will reflect the clinical trial portion of this project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major depressive disorder
- •Eligible to receive and recommended for rTMS for depression
- •Willingness to complete computerized cognitive training and undergo brain stimulation procedures
- •Must be enrolled as a Michigan Medicine patient and currently receiving TMS treatment as part of your clinical care.
排除标准
- •History of serious neurological illness or brain injury (e.g., stroke)
- •Poor visual acuity impairing performance on the computerized tasks (eyeglasses must be removed for rTMS treatment, but contacts are permissible)
- •Diagnosed intellectual disability
- •Inability to manipulate a tablet device while seated in the rTMS chair
研究组 & 干预措施
Computerized Cognitive Training (CCT)
The patients will receive CCT during their standard rTMS treatments (after having 5 days of treatment until the pre-taper treatment).
干预措施: Computerized Cognitive Training (CCT) (Other)
结局指标
主要结局
Feasibility assessed by percentage of CCT sessions completed during rTMS
时间窗: approximately 30 days (usually 20-30 sessions)
Percentage CCT sessions completed: (number of sessions completed/number of sessions assigned) X 100
次要结局
- Acceptability of CCT(through study completion date, up to 2 years)
- Time on task during treatment(For each day: 45 min; for entire treatment: approx 30 days)
- Cognitive Control Performance change over course of treatment(Approximately 30 days (usually 20-30 sessions))
研究者
Stephan F. Taylor
Professor of Psychiatry
University of Michigan