Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device - Safety and Feasibility Study for Treatment of Major Depressive Episode in the Elderly
试验速览
- 阶段
- 2 期
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Safety of the H1-Coil
研究概览
简要总结
Purpose: To evaluate the safety and anti-depressive response of the H1 Coil TMS Device in elderly patients suffering from major depressive episode.
Twenty-seven (27) treatment resistance depressed-patients, 68 years of age and above, currently in a depressive episode.All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.Safety and efficacy tests will be conducted before starting the trial (screening), once a week for the trial duration and one month following end of treatment.
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
- 68 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed by a senior psychiatrist as suffering from major depression episode according to DSM-IV (either as a part of a unipolar or a bipolar disorder).
- •Rating on HDRS ≥
- •Age: 68 years and above
- •Treated for the current depressive episode, at least 6 weeks per antidepressant with one antidepressant in accepted dose, without improvement, and/or intolerance to 2 antidepressants, according to medical chart and ATHF (antidepressant treatment history form) instruction guidelines.
- •Gave informed consent for participation in the study.
- •Negative answers on safety screening questionnaire for TMS.
- •If referred by a treating psychiatrist, he or she approves of the subject's participation in the study.
排除标准
- •Axis 2 diagnosis, which is considered prominent to the current depressive episode.
- •Substantial suicidal risk as judged by the treating psychiatrist or by an independent psychiatrist.
- •Attempted suicide in the past year.
- •Cognitive impermanent - if MMSE < 24, patient will be further assessed , and may be excluded according to the primary investigator's discretion
- •History of seizure.
- •History of epilepsy or seizure in first degree relatives.
- •Any CNS disorder that may increase risk of seizure significantly
- •History of a significant head injury.
- •History of any metal in the head (outside the mouth).
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- •History of frequent or severe headaches.
- •Use of hearing aids for hearing loss.
- •Known history of cochlear implants.
- •History of drug abuse or alcoholism.
- •Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- •Inadequate communication with the patient.
- •Under custodial care.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
- •Patients suffering from bipolar disorder, not currently treated by mood stabilizers
- •Patients declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
结局指标
主要结局
Safety of the H1-Coil
时间窗: One Month
maintaining subject's pre treatment, physical and neurological status.
Clinical antidepressant response
时间窗: One Month
a decline in Hamilton depression rating scale (HDRS) from the baseline rating by 50%.
次要结局
- Symptomatic improvement at the end point.(One Month)
- Clinical antidepressant remission(One Month)