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Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

NCT03785535 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-03-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Neurovoxel SLP

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03785535 on ClinicalTrials.gov