Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation 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.
|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|
- Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||August 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Active DSF-rTMS
Active rTMS treatment.
Effective Transcranial Magnetic Stimulation
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229852
|United States, Arizona|
|Premier Research Group|
|Phoenix, Arizona, United States, 85381|
|Study Chair:||M. Bret Schneider, M.D.||Cervel Neurotech, Inc.|