NCT03785535已完成不适用
Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
Neurovoxel SLP2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
研究概览
简要总结
The purpose of this study is to investigate the effects of low-intensity and prolonged vibrotactile sensory stimulation on brain activity and functional connectivity in fibromyalgia patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10).
- •Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
- •Diagnoses established by an expert on fibromyalgia.
- •Stable treatment of chronic use.
- •Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
排除标准
- •Generalized inflammatory articular or rheumatic disease.
- •Severe, non-stable medical, endocrinological or neurological disorder.
- •Psychotic disorder or drug abuse.
结局指标
主要结局
Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
时间窗: 3 weeks
Change on brain activity rated using functional MRI measures of functional connectivity
Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
时间窗: 3 weeks
Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation
次要结局
- Tolerability rated using a numerical rating scale ranging from 0 to 100 points.(3 weeks)
- Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.(3 weeks)
- Measured fibromyalgia symptoms using a 101-point numerical rating scale.(3 weeks)
研究者
Jesus Pujol
Principal Investigator
Neurovoxel SLP
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Sensory Stimulation in FibromyalgiaFibromyalgiaNCT03227952Jesus Pujol77
进行中（未招募）
不适用
Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's DiseaseParkinson's DiseaseNCT05830110Synergic Medical Technologies, Inc.30
已完成
2 期
Effect of vibratory orthosis on balance control in hemiparetic stroke patientsIRCT2012122611890N1Vice Chancellor For Research Of Iran University of Medical Science18
Unknown
不适用
Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)Vestibular DisorderNCT06300840Hanna van Eijsden8
已完成
不适用
Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee OsteoarthritisKnee OsteoarthritisNCT02605876University of North Carolina, Chapel Hill75