A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
In this pilot study, the PI proposes to include 20 African American participants with Fibromyalgia to explore the effect of r TMS on pain and depressive symptoms. The focus on African Americans is due to the mandate from the funding source (internal), as well as possible higher prevalence of FM in AA women. If recruitment is slow, the PI proposes to open up the study to other groups. Twenty subjects will be randomized to either sham or active TMS condition. Inclusion/exclusion criteria are well thought out and seem appropriate. mTreatments will be administered at IOP 5 times/wk with each session lasting 20 minutes. Pain intensity and unpleasantness will be measured pre and post each TMS session using three different pain evaluation paradigms. GCRC resource is mainly requested for two blood draws pre and post first TMS session. The blood samples will be used to measure inflammatory cytokines IL-1, IL-6, AND IL-8. The main aim is to ascertain feasibility of the study and secondary aim is to gather information on variability in response for power analysis for future larger study. The introduction and rationale (including pain evaluation, and methods relating to TMS) are clearly presented. Use of GCRC resources seem appropriate.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia|
- The Brief Pain Inventory
- The McGill Pain Questionnaire
- Fibromyalgia Impact Questionnaire
- Fibromyalgia Health Assesment Questionnaire
- The Beck Depression Inventory
- The Hamilton Depression Rating Scale
- Alteration in acute and chronic changes in IL-1, IL-6, IL-8
|Study Start Date:||July 2007|
Active Comparator: 1
Subjects are given TMS for 2 weeks.
Device: Neotonus model 2100 xxx
TMS stimulates cortical neurons by creating a time varying magnetic field generated by brief but powerful electrical currents. 59 high intensity current is rapidly turned on and off in the electromagnetic coil through the discharge of capacitors. The end result of TMS is thus electrical stimulation of the brain, and some refer to TMS as electrodeless electrical stimulation. Electrical energy stored in a capacitor discharges and creates about 3,000 Amps. Through Maxwell's equations and Faraday's law, this creates a powerful magnetic field, on the order of 2 Tesla. This rapidly changing magnetic field (~30KT/s) then travels across the scalp and skull and induces an electric field within the brain (~30V/m). This induces current to flow in the brain by creating a transmembrane potential (for a thorough discussion see 60). This localized pulsed magnetic field over the surface of the head depolarizes underlying superficial neurons 61, 62 which then induces electrical currents in the brain.
Sham Comparator: 2
Subjects are given sham TMS for 2 weeks.
Device: Neotonus model 2100 xxx
A specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active coils but is shielded so that actual stimulation does not occur. This approach is currently the state-of-the-art approach to sham TMS procedures and is employed in high-quality clinical TMS trials.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523302
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||E. Baron Short, MD||Medical University of South Carolina|