Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier:
NCT01229852
First received: October 25, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia.

The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.


Condition Intervention
Fibromyalgia
Device: DSF-rTMS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study

Resource links provided by NLM:


Further study details as provided by Cervel Neurotech, Inc.:

Primary Outcome Measures:
  • Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II) [ Time Frame: 1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment ] [ Designated as safety issue: No ]
  • Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment ] [ Designated as safety issue: No ]
  • Durability, safety and tolerability [ Time Frame: Measured weekly up to 1 month after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active DSF-rTMS
Active rTMS treatment.
Device: DSF-rTMS
Effective Transcranial Magnetic Stimulation

  Eligibility

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

Inclusion Criteria:

  • Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria.
  • Moderate or severe pain from fibromyalgia despite current treatment regimen.
  • Will not become pregnant during study.

Exclusion Criteria:

  • Seizure disorder.
  • Metal implants on or in brain, spinal cord, ear, eye or heart.
  • Current use of proconvulsant medications (e.g., bupropion).
  • Taking oral amitriptyline > 100 mg once daily at bedtime.
  • Nonscheduled analgesic, anticonvulsant or antidepressant medications.
  • Severe depression or suicidality.
  • Other significant psychiatric disorder.
  • Previous use of TMS.
  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: NCT01229852

Locations
United States, Arizona
Premier Research Group
Phoenix, Arizona, United States, 85381
Sponsors and Collaborators
Cervel Neurotech, Inc.
Investigators
Study Chair: M. Bret Schneider, M.D. Cervel Neurotech, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier: NCT01229852     History of Changes
Other Study ID Numbers: NS-CFS-FM-1
Study First Received: October 25, 2010
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cervel Neurotech, Inc.:
Fibromyalgia
Transcranial Magnetic Stimulation
Pain

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

ClinicalTrials.gov processed this record on October 23, 2014