CEFALY® Device in the Treatment of Patients With Fibromyalgia

Inclusion Criteria:

1. Aged from18 to 65 years

2. Diagnosed with FM according to the 2010 ACR Preliminary Diagnostic Criteria for
Fibromyalgia

3. Having a minimum pain score of at least 4 on the 0-10 FIQR pain scale at screening and
baseline

Exclusion Criteria:

1. Women: Pregnant, lactating or <6 months post partum

2. Episodic or Chronic Migraine according to the diagnostic criteria listed in ICHD-III
beta (2013) section 1, migraine 1, having two or more attacks per month.

3. Change in any medication acting on the central nervous system (CNS) within 28 days
before start of the study or during the study

4. Severe depression i.e. having a Beck Depression Inventory-Fast Screen (BDI-FS) score
>12

5. Botox injection within 4 months before baseline or during the study.

6. Psychiatric disorders that could interfere with study participation: bipolar disorder,
psychotic disorders and dementia.

7. Suicidal behavior and/or ideation i.e. having a Columbia Suicide Severity Rating Scale
(C-SSRS) score ≥ 4 during the preceding 2 years

8. Patients currently taking any opioid medication

9. Patients currently taking medically prescribed marijuana

10. Current or history during the preceding year of alcohol or substance abuse including
marijuana

11. Intolerance to supraorbital neurostimulation that makes the treatment not applicable
(test of nociceptive threshold with specific Cefaly program)

12. Widespread rheumatic diseases (other than FM), evidence of inflammatory rheumatic
disease

13. Any unstable medical condition in the judgment of the investigator that would
interfere with study participation or study assessments.

14. Implanted active metal or electrical devices in the head

15. Cardiac pacemaker or implanted or wearable defibrillator