Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01229852|
Recruitment Status : Completed
First Posted : October 28, 2010
Last Update Posted : May 19, 2014
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||Phase|
|Fibromyalgia||Device: DSF-rTMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Active DSF-rTMS
Active rTMS treatment.
Effective Transcranial Magnetic Stimulation
- Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ]
- 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 ]
- Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment ]
- Durability, safety and tolerability [ Time Frame: Measured weekly up to 1 month after treatment ]
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|
|Study Chair:||M. Bret Schneider, M.D.||Cervel Neurotech, Inc.|