Back to resultsFunctional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vibrotactile stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Generalized inflammatory articular or rheumatic disease.
- Severe, non-stable medical, endocrinological or neurological disorder.
- Psychotic disorder or drug abuse.
Sites / Locations
- Hospital del Mar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Actual treatment
Sham
Arm Description
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).
Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
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.
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
Tolerability index (0-100).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03785535
Brief Title
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
Official Title
Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
February 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Neurovoxel SLP
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Actual treatment
Arm Type
Experimental
Arm Description
Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (2-90 Hz), low intensity and long daily duration (3h).
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham treatment will be applied using identical instruments and with power and duration programmed identically. However, in this case, the output will not be the signal activating the vibration motors, but rather an electrical signal turning on an incorporated pilot light indicating that the (simulated) treatment was operating
Intervention Type
Device
Intervention Name(s)
Vibrotactile stimulation
Intervention Description
The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.
Primary Outcome Measure Information:
Title
Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
Description
Change on brain activity rated using functional MRI measures of functional connectivity
Time Frame
3 weeks
Title
Functional MRI measures of brain activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
Description
Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Functional MRI measures of sensory system activity. A functional MRI signal change scale ranging from 0 to 1 will be used.
Description
Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation
Time Frame
3 weeks
Title
Measured fibromyalgia symptoms using a 101-point numerical rating scale.
Description
Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.
Time Frame
3 weeks
Title
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
Description
Tolerability index (0-100).
Time Frame
3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Generalized inflammatory articular or rheumatic disease.
Severe, non-stable medical, endocrinological or neurological disorder.
Psychotic disorder or drug abuse.
Facility Information:
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
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