Cefaly® Device in the Treatment of Patients With Fibromyalgia.

NCT02546362 | Completed Results

• 1 other identifier: 50212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity (Fibromyalgia Impact Questionnaire-revised (FIQR) Pain Score) 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).

  between baseline and 12-week timepoint

• Change in Fibromyalgia Impact Questionnaire-revised (FIQR) Total Score 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.

  between baseline and 12-week timepoint

Secondary Outcomes (14)

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

  between baseline and 4-week timepoint

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

  between baseline and 4-week timepoint

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

  at 4-week timepoint

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

  at 12-week timepoint

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

  between baseline and 4-week timepoint

Study Arms (1)

Cefaly active device

EXPERIMENTAL

12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)

Device: Cefaly

Interventions

Cefaly DEVICE

Cefaly active device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Cefaly Technology: lead

Study Sites (1)

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trials Department director
• Organization: CEFALY Technology

info@cefaly.com

+32 4 367 67 22

Study Officials

• Lesley Arnold, M.D.

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

• Pierre Rigaux

  Cefaly Technology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: September 10, 2015
• Study Start: December 3, 2015
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: July 19, 2019
• Results First Posted: July 19, 2019

Record last verified: 2019-07

Locations

US (1)