Fibromyalgia Clinical Trial
Official title:
Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
Verified date | March 2021 |
Source | Neurovoxel SLP |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10). 2. Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion) 3. Diagnoses established by an expert on fibromyalgia. 4. Stable treatment of chronic use. 5. Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent. Exclusion Criteria: 1. Generalized inflammatory articular or rheumatic disease. 2. Severe, non-stable medical, endocrinological or neurological disorder. 3. Psychotic disorder or drug abuse. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Neurovoxel SLP |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used. | Change on brain activity rated using functional MRI measures of functional connectivity | 3 weeks | |
Primary | Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used. | Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation | 3 weeks | |
Secondary | Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used. | Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation | 3 weeks | |
Secondary | Measured fibromyalgia symptoms using a 101-point numerical rating scale. | Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales. | 3 weeks | |
Secondary | Tolerability rated using a numerical rating scale ranging from 0 to 100 points. | Tolerability index (0-100). | 3 weeks |
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