Clinical trial NCT02546362: Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Official title: A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Cefaly Technology
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged from18 to 65 years (on the day of signing the informed consent form).
2. Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia (ACR 2010).
3. 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:

1. Women: Pregnant, lactating or \<6 months post partum.
2. 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.
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. Widespread rheumatic diseases (other than fibromyalgia), evidence of inflammatory rheumatic disease.
12. Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments.
13. Implanted active metal or electrical devices in the head.
14. Cardiac pacemaker or implanted or wearable defibrillator.
15. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program).

Primary outcomes:
measure: Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
measure: Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
Secondary outcomes:
measure: Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Patient Global Impression of Change (PGIC) at 4-week Timepoint
timeFrame: at 4-week timepoint
measure: Patient Global Impression of Change (PGIC) at 12-week Timepoint
timeFrame: at 12-week timepoint
measure: Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
measure: Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint
timeFrame: between baseline and 4-week timepoint
measure: Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint
timeFrame: between baseline and 12-week timepoint
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Lesley Arnold, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cefaly Technology
name: Pierre Rigaux
role: STUDY_DIRECTOR
References: