A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.
| Registry | NCT02546362 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, treatment |
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| Enrollment | 50 (Actual) |
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| Sponsor | Cefaly Technology (Industry) |
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| Conditions | Fibromyalgia |
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| Interventions | Cefaly (Device) |
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| Dates | start 2015-12-03, primary completion 2018-05-15, completion 2018-05-15, first posted 2015-09-10, last updated 2019-07-19 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Fibromyalgia All trials of Cefaly
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Cefaly active device | Experimental | Device: Cefaly | 12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes) |
+Outcome measures
Primary outcomes
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint [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).
- Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint [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.
Secondary outcomes
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint [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).
- Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint [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.
- Patient Global Impression of Change (PGIC) at 4-week Timepoint [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).
- Patient Global Impression of Change (PGIC) at 12-week Timepoint [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).
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint [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).
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint [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).
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint [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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint [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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint [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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint [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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint [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.
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint [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.
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint [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.
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint [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.
+Eligibility
Sex: All, ages: 18 Years to 65 Years
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).
+Posted results
Participant flow
| Milestone | Cefaly Active Device |
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| Started | 50 |
| Completed | 47 |
| Not completed | 3 |
Outcome results
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint (Primary), Mean, score on a scale: Cefaly Active Device -1.33 +/- 2.41
- Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint (Primary), Mean, score on a scale: Cefaly Active Device -9.91 +/- 18.51
- Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -1.45 +/- 2.41
- Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -11.92 +/- 16.18
- Patient Global Impression of Change (PGIC) at 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device 3.36 +/- 1.11
- Patient Global Impression of Change (PGIC) at 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device 3.33 +/- 1.06
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device 5.79 +/- 15.32
- Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device 5.60 +/- 17.05
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -0.85 +/- 4.47
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -1.36 +/- 4.95
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -4.62 +/- 5.35
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -4.00 +/- 6.73
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -3.85 +/- 6.36
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -3.54 +/- 6.35
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -2.55 +/- 10.35
- Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint (Secondary), Mean, score on a scale: Cefaly Active Device -4.74 +/- 13.41
Adverse events
Time frame: The data was collected during the 12 weeks of the treatment period.
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Active | 0/50 (0.0%) | 0/50 (0.0%) | 40/50 (80.0%) |
Other adverse events by term
| Term | Organ system | Active |
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| Headache | Nervous system disorders | 11/50 |
| Nausea | Nervous system disorders | 2/50 |
| Neck pain | Nervous system disorders | 3/50 |
| Forehead pain during the session | Nervous system disorders | 7/50 |
| Persistence of sensation | Nervous system disorders | 1/50 |
| Sedative effect | Nervous system disorders | 9/50 |
| Skin reaction | Skin and subcutaneous tissue disorders | 7/50 |
| Tooth pain | Nervous system disorders | 2/50 |
| Eye watering, tears | Nervous system disorders | 2/50 |
| Shingles outbreak | Skin and subcutaneous tissue disorders | 1/50 |
| Worsening fibromyalgia | Musculoskeletal and connective tissue disorders | 1/50 |
| Dizziness | Nervous system disorders | 4/50 |
| Increase in sinus pain | Nervous system disorders | 1/50 |
| Spacey feeling | Nervous system disorders | 1/50 |
| Normal sensation of the Cefaly® device | Skin and subcutaneous tissue disorders | 12/50 |
| Burning sensation on forehead or scalp, in eyelids or eyebrows | Skin and subcutaneous tissue disorders | 2/50 |
| Heaviness in eyelids | Nervous system disorders | 2/50 |
| Forehead pressure | Nervous system disorders | 12/50 |
| Headache | Nervous system disorders | 4/50 |
| Sinus pressure | Nervous system disorders | 1/50 |
| Worsening IBS (Irritable Bowel Syndrome) | Renal and urinary disorders | 1/50 |
| Low back spasms | Musculoskeletal and connective tissue disorders | 1/50 |
| Flu infection, Cold virus infection, Sinus infection | Infections and infestations | 4/50 |
| Urinary tract infection | Renal and urinary disorders | 1/50 |
| Eczema | Skin and subcutaneous tissue disorders | 2/50 |
| Back pain and stiffness | Nervous system disorders | 1/50 |
| Worsening fatigue | Nervous system disorders | 1/50 |
| Sebaceous cyst | Skin and subcutaneous tissue disorders | 1/50 |
| Gastrointestinal virus | Infections and infestations | 2/50 |
| Right knee injury | Surgical and medical procedures | 1/50 |
| Multiple joint pain | Musculoskeletal and connective tissue disorders | 1/50 |
| Back strain | Musculoskeletal and connective tissue disorders | 2/50 |
| Tubal ligation | Surgical and medical procedures | 1/50 |
| Increase in depression | Psychiatric disorders | 1/50 |
| Rash on ankles | Skin and subcutaneous tissue disorders | 1/50 |
| Diarrhea | Gastrointestinal disorders | 2/50 |
| Vertigo | Nervous system disorders | 1/50 |
| Blurred vision | Nervous system disorders | 1/50 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | 2/50 |
| Viral respiratory illness | Infections and infestations | 1/50 |
| Panic attack | Psychiatric disorders | 1/50 |
| Restlessness | Nervous system disorders | 2/50 |
| Worsening right knee or foot pain | Nervous system disorders | 2/50 |
| Swollen right thigh and knee | Musculoskeletal and connective tissue disorders | 1/50 |
| Ringing in the ears/Ears ache | Ear and labyrinth disorders | 3/50 |
| Burning sensation in both legs and right shoulder | Skin and subcutaneous tissue disorders | 1/50 |
| Body tingling | Skin and subcutaneous tissue disorders | 1/50 |
| Cold sensation in left cheek | Nervous system disorders | 1/50 |
+Locations (1)
| Facility | City | Country | Status |
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| University of Cincinnati College of Medicine | Cincinnati, Ohio | United States | |
+Study documents
+Investigators