Repetitive Transcranial Magnetic Stimulation (rTMS) for Orthopaedic Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for orthopaedic trauma patients. In this open label study, all participants will receive accelerated theta-burst stimulation. This study will examine whether symptoms of psychiatric distress and opioid use in orthopaedic trauma patients can be mitigated with rTMS to improve post-injury recovery.
详细描述
A large percentage of orthopaedic trauma patients suffer from psychiatric distress and chronic pain related to their injury and underlying psychosocial factors; this predicts poor post-injury recovery.
Repetitive transcranial magnetic stimulation (rTMS) is a neuromodulation technique used to stimulate areas of the brain that may modulate symptoms of pain, depression, and post-traumatic stress. The FDA-approved rTMS protocol for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC) for the treatment of depression. This methodology has been very successful in real world situations, however poses some limitations, including the duration of the treatment session (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study will use modified parameters to create a more rapid form of treatment and look at outcome changes in pain and depression, commonly seen in orthopaedic trauma patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 65 years of age.
- •Able to provide informed consent.
- •Present to Stanford Emergency Department as a trauma with a major operative lower extremity injury
- •Glasgow coma scale of 15 within 24 hours after admission or extubation
- •Negative urinary toxicology screen for illicit substances;
- •Negative pregnancy test if female and less then 60 y/o;
- •No suspicion for a head injury and/or negative head CT scan for intracranial hemorrhage or injury based on standard of care
- •No history of seizure disorder or other neurological disorders.
- •All patients included must screen positive for PHQ-9 score >4 (positive symptoms of depression) and CES-T score <36 (poor coping self-efficacy).
排除标准
- •Incarceration,
- •Pregnant females,
- •Prior psychotic disorder,
- •Current use of anti-depressant or anti-psychotic medications,
- •Prior-admission opioid use within 30 days (patients will be screened for recent prescription opioid use using the CURES report),
- •Heavy alcohol use,
- •Lesional neurological disorder or brain implant or intracranial ferromagnetic material,
- •Seizure disorder
结局指标
主要结局
Change from baseline in the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire)
The Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983) is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale (0 to 3). Overall scores range from 0 to 42, with lower scores corresponding to fewer symptoms. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states; each subscale score ranges from 0 to 21, with lower scores corresponding to fewer symptoms. Scores of greater than or equal to 11 on either HADS-A or HADS-D scales indicate a definitive case of anxiety and/or depression, respectively.
次要结局
- Change from baseline in the Numeric Pain Rating Scale (NRS)(Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire))
- Change from baseline in the PTSD Checklist for DSM-5 (PCL-5)(Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire))
- Change from baseline in the Trauma Coping Self-Efficacy (CSE-T) scale(Baseline and immediate post-stimulation (up to 10 minutes to complete questionnaire))
研究者
Nolan R
Assistant Professor, Director of Interventional Psychiatry Clinical Research, Department of Psychiatry and Behavioral Sciences, Stanford University Medical Center
Stanford University