Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: Vibrotactile stimulation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 8003
    • Hospital del Mar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actual treatment; 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).	Device: Vibrotactile stimulation; 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.
Sham Comparator: Sham; 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	Device: Vibrotactile stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.	Tolerability index (0-100).	3 weeks

Collaborators and Investigators

• Sponsor: Neurovoxel SLP

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): February 28, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PSI2017-83777-P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No