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: January 20, 2014
Last verified: January 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
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: January 20, 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
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014