Cefaly® Device in the Treatment of Patients With Fibromyalgia.

Completed · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT02546362

Run by

Cefaly Technology

People needed

50

Starts

2015-12-03

Expected to finish

2018-05-15

Last updated by the study team

2019-07-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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