Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785535
• Other study ID #: PSI2017-83777-P
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2021
• Source: Neurovoxel SLP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Neurovoxel SLP

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Tolerability rated using a numerical rating scale ranging from 0 to 100 points.	Tolerability index (0-100).	3 weeks