Synchronized Cervical or Auricular VNS With Prefrontal rTMS for Treatment Resistant Depression (TRD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale
研究概览
简要总结
The purpose of the research is to test out a combined treatment for depression where the investigators stimulate a nerve in the ear while at the same time stimulate the brain with magnets. These treatments are called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) and transcranial (through the skull) magnetic stimulation (TMS). For participants who already have a cervical VNS device, the investigators will not change their treatment and will use this in place of the taVNS. The investigators think this combined method might treat depressive symptoms better than either alone. This study is in person at the Institute of Psychiatry in downtown Charleston on the MUSC campus. First, participants will have a screening session and then will have 6 treatment days total where participants will receive either VNS treatment alone, TMS treatment alone, or both at the same time. The treatment that participants start with will be randomized, and they will have 2 treatment days of each combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Undergoing cervical VNS or have tried and failed two antidepressant medications in the current episode
- •Able to provide informed consent
- •English speaking and can read and write
- •17-item Hamilton Depression Rating Scale (HAM-D) score ≥20
- •Not responding to talking therapy.
排除标准
- •Preexisting neurological disorders, or dementia
- •History of major head trauma
- •Life expectancy <1 year
- •Any type of cognitive impairment that would require approval/signature of a legal guardian/representative for participation
- •A score of >2 on question 3 of the Hamilton Depression Rating pertaining to suicidality
- •Current active suicidal intent or plan, prior attempt within the last 6 months, or who in the judgment of the investigator would be at elevated risk for suicide will be excluded
- •Patients who are pregnant will also be excluded. We will require a pregnancy test for individuals of child-bearing potential.
研究组 & 干预措施
Synchronized VNS and TMS
干预措施: Vagus Nerve Stimulation (Device)
Synchronized VNS and TMS
干预措施: Transcranial Magnetic Stimulation (Device)
Vagus Nerve Stimulation (VNS) only
干预措施: Vagus Nerve Stimulation (Device)
Transcranial Magnetic Stimulation (TMS) only
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Change in Hamilton Depression Rating Scale
时间窗: Through study completion, an average of 8 weeks
The Hamilton Depression Rating Scale (HDRS) is a commonly used clinician-administered depression rating scale to assess severity of depressive symptoms. The HDRS has a possible score range of 0-52. The higher the HDRS score, the more severe the depressive symptoms are in that patient.
Change in Patient Health Questionnaire 9
时间窗: Through study completion, an average of 8 weeks
The Patient Health Questionnaire 9 (PHQ-9) is a brief self-administered questionnaire to assess depressive symptoms. The PHQ-9 has a possible score range of 0-27. The higher the PHQ-9 score, the more severe the depressive symptoms are in that patient.
次要结局
- Number of adverse outcomes(One month following conclusion of the trial)
- Number of adverse outcomes(One week following conclusion of the trial)
研究者
Mark George
Principal Investigator
Medical University of South Carolina