Cefaly® Device in the Treatment of Patients With Fibromyalgia.

Study Overview
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Brief Summary
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The objective of this pilot open trial was to assess the efficacy and safety of external trigeminal nerve stimulation (e-TNS) with the Cefaly® device in fibromyalgia.

Detailed Description
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The main objective of this clinical pilot trial was to evaluate the use of external trigeminal nerve stimulation (e-TNS) with the Cefaly® neurostimulator device as a new therapeutic treatment for fibromyalgia.

Official Title
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A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Device: Cefaly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged from18 to 65 years (on the day of signing the informed consent form). Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010). Having a minimum pain score of at least 4 on the 0-10 Fibromyalgia Impact Questionnaire-revised (FIQR) pain scale at screening and baseline. Exclusion Criteria: Women: Pregnant, lactating or <6 months post partum. Episodic or Chronic Migraine according to the diagnostic criteria listed in International Classification of Headache Disorders (ICHD)-3 beta (2013) section 1, migraine 1, having two or more attacks per month. Change in any medication acting on the central nervous system (CNS) within 28 days before start of the study or during the study. Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score >12. Botox injection within 4 months before baseline or during the study. Psychiatric disorders that could interfere with study participation: bipolar disorder, psychotic disorders and dementia. Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale (C-SSRS) score ≥ 4 during the preceding 2 years. Patients currently taking any opioid medication. Patients currently taking medically prescribed marijuana. Current or history during the preceding year of alcohol or substance abuse including marijuana. Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease. Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments. Implanted active metal or electrical devices in the head. Cardiac pacemaker or implanted or wearable defibrillator. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cefaly active device<br>12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) | Device: Cefaly<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint | Pain intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) pain score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | between baseline and 12-week timepoint | 
| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | between baseline and 12-week timepoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint | Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) is defined on a numeric rating scale scoring the pain between 0 (=no pain) and 10 (=unbearable pain). | between baseline and 4-week timepoint | 
| Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint | Fibromyalgia Impact Questionnaire-revised (FIQR) total score is ranging from 0 to 100, where lower score corresponds to a better quality of life. | between baseline and 4-week timepoint | 
| Patient Global Impression of Change (PGIC) at 4-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | at 4-week timepoint | 
| Patient Global Impression of Change (PGIC) at 12-week Timepoint | Patient Global Impression of Change (PGIC) is defined on a 7-level scale where 1=very much improved and 7=very much worse (4=no change). | at 12-week timepoint | 
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | between baseline and 4-week timepoint | 
| Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint | EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS score is defined on a Visual Analogue Scale (VAS) ranging from 0 (= worth imaginable health state) to 100 (=best imaginable health state). | between baseline and 12-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | between baseline and 4-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for depression is ranging from 8 to 40 where higher score is associated with higher depression level. | between baseline and 12-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | between baseline and 4-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for fatigue is ranging from 8 to 40 where higher score is associated with higher fatigue level. | between baseline and 12-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | between baseline and 4-week timepoint | 
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint | Patient Reported Outcomes Measurement Information System (PROMIS) score for sleep disturbance is ranging from 8 to 40 where higher score is associated with higher sleep disturbance level. | between baseline and 12-week timepoint | 
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | between baseline and 4-week timepoint | 
| Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint | Multiple Ability Self-report Questionnaire (MASQ) score is ranging from 38 to 190, where higher score indicates more difficulty. | between baseline and 12-week timepoint |