Cefaly® Device in the Treatment of Patients With Fibromyalgia.

NCT ID: NCT02546362

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-03
• Study Completion Date: 2018-05-15

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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cefaly active device

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

Group Type: EXPERIMENTAL

Cefaly

Intervention Type: DEVICE

Interventions

Cefaly

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cefaly Technology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lesley Arnold, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Pierre Rigaux

Role: STUDY_DIRECTOR

Cefaly Technology

Locations

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

50212

Identifier Type: -

Identifier Source: org_study_id