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Completed

NCT Number: NCT03785535

Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 8003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  1. Functional MRI measures of sensory system 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 non-nociceptive stimulation

  2. Measured fibromyalgia symptoms using a 101-point numerical rating scale.

    Time frame: 3 weeks

    Change on fibromyalgia symptoms (including pain, fatigue, cognitive symptoms, sleep disturbance, and general health rating). Rated using Numerical Rating 101-point Scales.

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

    Time frame: 3 weeks

    Tolerability index (0-100).

Sponsors and collaborators

Lead sponsor

Neurovoxel SLP

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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