Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation (dTMS) as a Treatment for Patients With Fibromyalgia
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- change in self-reported average pain intensity over the last 24 hours
研究概览
简要总结
Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS.
Design: Prospective randomized sham controlled trial Study Population & sample size:forty (40) FMS subjects between 18-80 years of age.
No. of Centers: Four centers-
- Shalvata Mental Health Center, Tel -Aviv University, Israel.
- Soraski medical center, Tel-Aviv University, Israel.
- Sheba Medical Center, Tel-Aviv University, Israel
- Beer-Yakov Mental Health Center, Tel-Aviv University, Israel. Duration and intensity of Treatment: All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
Name of device: The Brainsway Ltd. H1-Coil
Study Endpoints: Clinical outcome:
primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ.
secondary outcome
- Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire.
- Change of the impact of pain and FMS on quality of life, will be measured at the end point using the BPI items for pain interference.
- change of sensitivity to painful stimuli will be evaluated by physical measurements:
- WPI
- SSS
- Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
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
- Single (Participant)
盲法说明
participants do not know if they are getting the DTMS treatment or sham.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years.
- •Patients who continue to take their administered medications or patients who stopped ineffective administered medications
- •Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
- •Gave informed consent for participation in the study.
排除标准
- •Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
- •Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
- •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 head injury.
- •History of seizure or heat convulsion.
- •History of epilepsy or seizure in first degree relatives.
- •History of frequent or severe headaches.
- •Use of hearing aids for hearing loss.
- •Known history of cochlear implants.
- •History of drug abuse or alcoholism during the last year.
- •Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- •Significant difficulties in language or communication.
- •Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
研究组 & 干预措施
FM group
patients diagnosed with Fibromyalgia receiving dTMS treatment.
干预措施: prefrontal deep rTMS of H1 Coil (Device)
placebo group
patients diagnosed with Fibromyalgia receiving sham- treatment.
干预措施: prefrontal deep rTMS of H1 Coil (Device)
结局指标
主要结局
change in self-reported average pain intensity over the last 24 hours
时间窗: at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)
self-reported average pain intensity over the last 24 hours will be measured with numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ- self-reported average pain intensity scale
次要结局
- Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition(baseline and end point (after 4 weeks))
- Change of the impact of pain and FMS on quality of life(at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments))
- Change of sensory and affective pain dimensions(at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments))