Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients

Neurovoxel SLP1 site in 1 country60 target enrollmentJanuary 15, 2019

ConditionsFibromyalgia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Neurovoxel SLP
Enrollment: 60
Locations: 1
Primary Endpoint: Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 15, 2019

End Date

February 28, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Neurovoxel SLP

Responsible Party

Principal Investigator

Jesus Pujol

Principal Investigator

Neurovoxel SLP

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.

Outcomes

Primary Outcomes

Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used.

Time Frame: 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.

Time Frame: 3 weeks

Change on brain activity rated using functional MRI measures of brain activation in response to nociceptive stimulation

Secondary Outcomes

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)