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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01229852
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Cervel Neurotech, Inc.

Brief Summary:

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 or disease Intervention/treatment
Fibromyalgia Device: DSF-rTMS

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study
Study Start Date : August 2010
Primary Completion Date : September 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active DSF-rTMS
Active rTMS treatment.
Device: DSF-rTMS
Effective Transcranial Magnetic Stimulation

Primary Outcome Measures :
  1. Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment ]
  3. Durability, safety and tolerability [ Time Frame: Measured weekly up to 1 month after treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229852

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

Responsible Party: Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier: NCT01229852     History of Changes
Other Study ID Numbers: NS-CFS-FM-1
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

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

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