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OpenTrials
Completed

NCT Number: NCT02546362

Cefaly® Device in the Treatment of Patients With Fibromyalgia.

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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

CEFALY

Device

Primary outcomes

  1. Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 12-week Timepoint

    Time frame: 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).

  2. Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 12-week Timepoint

    Time frame: 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

  1. Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) Between Baseline and 4-week Timepoint

    Time frame: 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).

  2. Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score Between Baseline and 4-week Timepoint

    Time frame: 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.

  3. Patient Global Impression of Change (PGIC) at 4-week Timepoint

    Time frame: 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).

  4. Patient Global Impression of Change (PGIC) at 12-week Timepoint

    Time frame: 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).

  5. Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 4-week Timepoint

    Time frame: 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).

  6. Change in EuroQol 5-dimensions - 3-level (EQ-5D-3L) VAS Score Between Baseline and 12-week Timepoint

    Time frame: 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).

  7. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 4-week Timepoint

    Time frame: 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.

  8. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Depression Between Baseline and 12-week Timepoint

    Time frame: 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.

  9. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 4-week Timepoint

    Time frame: 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.

  10. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Fatigue Between Baseline and 12-week Timepoint

    Time frame: 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.

  11. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 4-week Timepoint

    Time frame: 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.

  12. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Measure for Sleep Disturbance Between Baseline and 12-week Timepoint

    Time frame: 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.

  13. Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 4-week Timepoint

    Time frame: 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.

  14. Change in Multiple Ability Self-report Questionnaire (MASQ) Between Baseline and 12-week Timepoint

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cefaly Technology

Industry

Registry information

Official study title

A Single Center, Pilot, Open Trial of the Cefaly® Device in the Treatment of Patients With Fibromyalgia.

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2015
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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