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Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03785535
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jesus Pujol, Neurovoxel SLP

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Vibrotactile stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785535


Contacts
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Contact: Jesus Pujol, MD 34935892827 21404jpn@comb.cat
Contact: Joan Deus, PhD 34696922078 Joan.Deus@uab.cat

Locations
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Spain
Hospital del Mar Recruiting
Barcelona, Spain, 8003
Contact: Jesus d Pujol, MD    34932483091 ext 34932483091    21404jpn@comb.cat   
Contact: Jesus d Pujol    34932483091 ext 34932483091    21404jpn@comb.cat   
Principal Investigator: Jesus d Pujol, MD         
Sponsors and Collaborators
Neurovoxel SLP

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Responsible Party: Jesus Pujol, Principal Investigator, Neurovoxel SLP
ClinicalTrials.gov Identifier: NCT03785535     History of Changes
Other Study ID Numbers: PSI2017-83777-P
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases