Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Hamilton Rating Scale for Depression
研究概览
简要总结
The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •All racial and ethnic groups
- •Ages 18 to 65
- •Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
- •History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry
- •Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
- •Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
- •Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
- •No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
- •No contraindications to MRI (passes MRI safety screening questionnaire)
- •Able to commit to the treatment schedule
- •Able to complete assessment procedures in English
- •Intact decision-making capacity and ability to provide voluntary informed consent
排除标准
- •History of moderate, severe, or penetrating TBI
- •History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy
- •Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed
- •Active manic or psychotic illness per MINI
- •Current substance use disorder per MINI
- •Current active suicidal or homicidal ideation
- •Pregnant or intending to become pregnant within the study period; breastfeeding
- •Other sensory conditions or illnesses precluding participation in assessments or treatment
- •Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy
- •Taking medication that lowers seizure threshold
- •Previous failed treatment with rTMS, iTBS, or ECT
- •Completed >4 sessions of cognitive rehabilitation within the last 3 years
研究组 & 干预措施
PACT+iTBS
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
干预措施: iTBS (Device)
PACT+iTBS
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks)
干预措施: Personalized, Augmented Cognitive Training (PACT) (Behavioral)
PACT+sham iTBS
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
干预措施: sham iTBS (Device)
PACT+sham iTBS
Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks)
干预措施: Personalized, Augmented Cognitive Training (PACT) (Behavioral)
结局指标
主要结局
Hamilton Rating Scale for Depression
时间窗: change over 8 weeks
次要结局
- WAIS-IV Processing Speed(change over 8 weeks)
- PROMIS Cognitive Function Abilities Short Form(change over 8 weeks)
- WMS-IV Digit Span(change over 8 weeks)
- Hopkins Verbal Learning Test - Revised(change over 8 weeks)
- Patient Health Questionnaire-9(change over 8 weeks)
- Neurobehavioral Symptom Inventory(change over 8 weeks)
- PTSD Checklist for DSM-5(change over 8 weeks)
- Headache Impact Test(change over 8 weeks)
- Pittsburgh Sleep Quality Index(change over 8 weeks)
- WHO Disability Assessment Schedule(change over 8 weeks)
- Glasgow Outcome Scale - Extended(change over 8 weeks)
- Traumatic Brain Injury Quality of Life(change over 8 weeks)
- Patient Global Impression of Change(rating at 8 weeks)
- D-KEFS Trail Making Test(change over 8 weeks)
- D-KEFS Color Word Interference Test(change over 8 weeks)
- UCSD Performance-Based Skills Assessment-Brief(change over 8 weeks)
研究者
Elizabeth Twamley
Professor of Psychiatry
University of California, San Diego