Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

NCT03785535 | Completed

• 1 other identifier: PSI2017-83777-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• Tolerability rated using a numerical rating scale ranging from 0 to 100 points.

  3 weeks

Study Arms (2)

Actual treatment

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

Vibrotactile stimulation DEVICE

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.

Actual treatment; Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Care Res 2010;62:600-10).
• 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.

You may not qualify if:

• Generalized inflammatory articular or rheumatic disease.
• Severe, non-stable medical, endocrinological or neurological disorder.
• Psychotic disorder or drug abuse.

Sponsors & Collaborators

• Neurovoxel SLP: lead

Study Sites (1)

Hospital del Mar

Barcelona, 8003, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: January 15, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: March 3, 2021

Record last verified: 2021-03

Locations

ES (1)