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

October 25, 2010
January 20, 2014
August 2010
September 2011   (final data collection date for primary outcome measure)
Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01229852 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II) [ Time Frame: 1, 10, 20 day of treatment ] [ Designated as safety issue: No ]
  • Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II) [ Time Frame: Week 1, 3, 7, 12 of post treatment ] [ Designated as safety issue: No ]
  • Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1, 10, 20 day of treatment ] [ Designated as safety issue: No ]
  • Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Week 1, 3, 7, 12 of post treatment ] [ Designated as safety issue: No ]
  • Durability, safety and tolerability [ Time Frame: Measured weekly up to 3 months after treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Device: DSF-rTMS
Effective Transcranial Magnetic Stimulation
Experimental: Active DSF-rTMS
Active rTMS treatment.
Intervention: Device: DSF-rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01229852
NS-CFS-FM-1
No
Cervel Neurotech, Inc.
Cervel Neurotech, Inc.
Not Provided
Study Chair: M. Bret Schneider, M.D. Cervel Neurotech, Inc.
Cervel Neurotech, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP