FibromyalgiaNCT03785535
Functional MRI Study of Vibrotactile Stimulation Effects in Fibromyalgia
A study testing Vibrotactile stimulation in people with Fibromyalgia, run by Neurovoxel SLP at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Vibrotactile stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Generalized inflammatory articular or rheumatic disease.
- Severe, non-stable medical, endocrinological or neurological disorder.
- Psychotic disorder or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
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
- Being tested
- Vibrotactile stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrotactile stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Device: Vibrotactile stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Change on brain activity rated using functional MRI measures of brain activation in response to non-nociceptive stimulation
Measured: 3 weeks
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.
Measured: 3 weeks
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
Tolerability index (0-100).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start15 Jan 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovoxel SLP
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesus Pujol, Neurovoxel SLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785535
- Sponsor's protocol ID
- PSI2017-83777-P
- Status last verified
- Mar 2021
- First submitted
- 20 Dec 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI Study of the Effects of Vibrotactile Sensory Stimulation on Brain Activity in Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT03785535
- Acronym / sponsor ID
- PSI2017-83777-P
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Neurovoxel SLPUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actual treatment | Experimental | Device: Vibrotactile stimulationVibrotactile 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). |
| Sham | Sham comparator | Device: Vibrotactile stimulationSham 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Generalized inflammatory articular or rheumatic disease.
- Severe, non-stable medical, endocrinological or neurological disorder.
- Psychotic disorder or drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrotactile stimulationThe 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. | Device | Actual treatment, Sham |
Primary outcome
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
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
3 secondary outcomes
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
Measured fibromyalgia symptoms using a 101-point numerical rating scale.
Time frame: 3 weeks
Tolerability rated using a numerical rating scale ranging from 0 to 100 points.
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrotactile stimulation in people with Fibromyalgia, run by Neurovoxel SLP at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional MRI measures of brain functional connectivity. A correlation scale ranging from 0 to 1 will be used. (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.