Completed
A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
What is being tested
Cefaly
Device
Who is being recruted
Fibromyalgia+3
+ Muscular Diseases
+ Musculoskeletal Diseases
From 18 to 65 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: December 2015
Summary
Principal SponsorCefaly Technology
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 3, 2015
Actual date on which the first participant was enrolled.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 TitleA Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
Principal SponsorCefaly Technology
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
FibromyalgiaMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeuromuscular DiseasesRheumatic Diseases
Criteria
3 inclusion criteria required to participate
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.
15 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimental12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
University of Cincinnati College of Medicine
Cincinnati, United StatesOpen University of Cincinnati College of Medicine in Google MapsCompletedOne Study Center