Trial record 39 of 139 for:    fibromyalgia | Open Studies | Interventional Studies

CEFALY® Device in the Treatment of Patients With Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Cefaly Technology
Sponsor:
Information provided by (Responsible Party):
Cefaly Technology
ClinicalTrials.gov Identifier:
NCT02546362
First received: September 9, 2015
Last updated: July 26, 2016
Last verified: July 2016
  Purpose
The objective of this pilot open trial is to investigate the efficacy and safety of e-TNS with the Cefaly(R) device in fibromyalgia.

Condition Intervention Phase
Fibromyalgia
Device: Cefaly
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single Center, Pilot, Open Trial of the CEFALY® Device in the Treatment of Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Cefaly Technology:

Primary Outcome Measures:
  • Change in mean pain intensity between baseline and 12 weeks endpoint [ Time Frame: Baseline and 12 weeks endpoint ] [ Designated as safety issue: No ]
  • Change in Fibromyalgia Impact Questionnaire-revised (FIQR) total score between baseline and 12 weeks endpoint [ Time Frame: Baseline and 12 weeks endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in mean pain intensity between baseline and 4 weeks visit [ Time Frame: Baseline and 4 weeks visit ] [ Designated as safety issue: No ]
  • Change in FIQR between baseline and 4 weeks visit [ Time Frame: Baseline and 4 weeks visit ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) at 4 weeks visit and at 12 weeks endpoint [ Time Frame: 4 weeks visit and at 12 weeks endpoint ] [ Designated as safety issue: No ]
  • Change in EQ-5D-3L between baseline and 4 weeks visit; and between baseline and 12 weeks endpoint [ Time Frame: Baseline and 4 weeks visit; baseline and 12 weeks endpoint ] [ Designated as safety issue: No ]
  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) measures for depression, fatigue and sleep between baseline and 4 weeks visit; and between baseline and 12 weeks endpoint [ Time Frame: Baseline and 4 weeks visit; baseline and 12 weeks endpoint ] [ Designated as safety issue: No ]
  • Change in Multiple Ability Self-report Questionnaire (MASQ) between baseline and 4 weeks visit; and between baseline and 12 weeks endpoint [ Time Frame: Baseline and 4 weeks visit; baseline and 12 weeks endpoint ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • FM30 (≥30% responder rate) [ Time Frame: 12 weeks endpoint ] [ Designated as safety issue: No ]
  • FM20 (≥20% responder rate) [ Time Frame: 12 weeks endpoint ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2015
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
12 weeks of treatment using Cefaly twice a day (treatment session of 20 minutes)
Device: Cefaly

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged from18 to 65 years
  2. Diagnosed with FM according to the 2010 ACR Preliminary Diagnostic Criteria for Fibromyalgia
  3. Having a minimum pain score of at least 4 on the 0-10 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 ICHD-III 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. Intolerance to supraorbital neurostimulation that makes the treatment not applicable (test of nociceptive threshold with specific Cefaly program)
  12. Widespread rheumatic diseases (other than FM), evidence of inflammatory rheumatic disease
  13. Any unstable medical condition in the judgment of the investigator that would interfere with study participation or study assessments.
  14. Implanted active metal or electrical devices in the head
  15. Cardiac pacemaker or implanted or wearable defibrillator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02546362

Contacts
Contact: Lesley M. Arnold ARNOLDLM@UCMAIL.UC.EDU

Locations
United States, Ohio
University of Cincinnati College of Medicine Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Lesley M. Arnold       ARNOLDLM@UCMAIL.UC.EDU   
Sponsors and Collaborators
Cefaly Technology
  More Information

Responsible Party: Cefaly Technology
ClinicalTrials.gov Identifier: NCT02546362     History of Changes
Other Study ID Numbers: 50212 
Study First Received: September 9, 2015
Last Updated: July 26, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 30, 2016