Pilot Study: Evaluating the Feasibility of Repetitive Transcranial Magnetic Stimulation Treatment Delivered at Individual-based, SCC-determined Frequency in Subjects Suffering From Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Inventory of Depressive Symptoms-Self-report scores
研究概览
简要总结
This study will investigate the feasibility, safety, and tolerability of administering repetitive Transcranial magnetic stimulation(TMS) at frequencies other than standard 10 Hz. This study will enroll 10 subjects who will undergo one quantitative electroencephalograph, one TMS procedure to determine the appropriate frequency and intensity for treatment, weekly mood/symptom assessments, and up to 30 TMS treatments. Subjects will be asked to participate for up to 6 weeks.
详细描述
STUDY OBJECTIVE
The primary objective of this study is to demonstrate feasibility of repetitive Transcranial Magnetic Stimulation (rTMS) treatment for depression at stimulation frequencies other than 10 Hz. The objectives for this study are:
- to determine if each subject's frequency response pattern shows one or more distinct frequencies of stimulation that generated increased Spectral Correlation Coefficient;
- to determine if these frequency response patterns differ across subjects; and,
- To gather pilot data for an extramural funding application to investigate the efficacy of rTMS treatment at individualized stimulation frequencies as an alternative to the standard 10 Hz protocol.
INCLUSION/EXCLUSION CRITERIA
We will enroll 10 subjects into this study. Subjects must meet all the following inclusion criteria to qualify for enrollment:
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
盲法说明
Participants will receive TMS treatment however, we will not disclose the frequency they will be treated at. Each Subject will receive 75 trains of 40 pulses every 26 secs however, the frequency may differ.
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
- •All subjects must be over between 18-75 years of age.
- •Must have confirmed diagnosis of severe Major Depressive Disorder (single or recurrent episode).
- •Failure to respond to a minimum of 2 trials of antidepressant medication
- •Failure to respond from at least two different agent classes
- •Accompanied by at least two evidence-based augmentation therapies (Benzodiazepines
- •do not count).
- •Must have a trial of psychotherapy known to be effective in the treatment of MDD of an adequate frequency and duration.
- •Subjects are willing and able to adhere to the treatment schedule and required study visits
排除标准
- •Are mentally or legally incapacitated, unable to give informed consent
- •Have an infection or poor skin condition over the scalp where the device will be positioned
- •Have increased risk of seizure because of family history, stroke, or currently use medications that lead to increased risk for seizure
- •Diagnosis of acute or chronic psychotic symptoms or disorders (such as schizophrenia, schizophreniform or schizoaffective disorder) in the current depressive episode.
- •Neurological conditions that include epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
- •Presence of an implanted magnetic-sensitive medical device located less than or equal to 30 centimeters from the transcranial magnetic stimulation magnetic coil or other implanted metal items, including but not limited to a cochlear implant, implanted cardioverter defibrillator, pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents. (Note: Dental amalgam fillings are not affected by the magnetic field and are acceptable for use with transcranial magnetic stimulation
结局指标
主要结局
Change in Inventory of Depressive Symptoms-Self-report scores
时间窗: Throughout study completion, 6 weeks on average
Scores range from 0 to 84, a higher score indicates a worse outcome, a decrease in scores indicated a positive outcome.
次要结局
未报告次要终点
研究者
Andrew F. Leuchter
Principal investigator
University of California, Los Angeles