A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Fibromyalgia; Major Depression

Treatments: Device: Sham TMS; Device: Active TMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00523302

HR#17365

AR049459 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-80,
• meet ACR criteria for FM for more than 6 months,
• may or may not have a diagnosis of major depressive disorder (not bipolar) past or present,
• Current major depressive episode must be without psychotic features
• Not be on medication known to increase risk of TMS-induced seizures
• No prescription medication changes in the previous 4 weeks with agreement not to change during the treatment course (2 weeks) and 2 weeks thereafter
• No history of epilepsy or stroke or recent head trauma (LOC > 5 minutes) within the past 6 months
• African Americans will be initially sought out for study, however the recruitment may extend to include Caucasian and Hispanic subjects to carry out the study.

Exclusion criteria

• Primary, current diagnosis of schizophrenia
• Other (non-mood disorder) psychosis
• Mental retardation
• Substance dependence or abuse within the past 6 months (except nicotine)
• Psychotic features in this episode, dementia, or delirium
• Contraindication to rTMS
• Increased intracranial pressure
• Brain surgery, or head trauma with loss of consciousness for > 15 minutes
• Implanted electronic device
• Metal in the head, or pregnant
• Has an active autoimmune, endocrine, viral, or vascular disorder affecting the brain or unstable cardiac disease
• Uncontrolled hypertension, or severe renal or liver insufficiency
• Unstable and active suicidal intent or plan
• History of attempt requiring medical hospitalization within in the past 6 months
• -currently an involuntary inpatient on a psychiatric ward.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Active TMS

Active Comparator group

Description:

Since cortical stimulation can be performed non-invasively by active Transcranial Magnetic Stimulation (TMS), Participants in the active TMS group, receive five 20 minute active TMS treatment sessions per week for two weeks.

Treatment:

Device: Active TMS

Sham TMS

Sham Comparator group

Description:

To prevent unwanted cortical activation, Sham TMS will be employed in the Sham TMS group. For the Sham TMS group, a specially designed sham TMS coil will be used for all sham conditions. This sham TMS coil produces auditory signals identical to active TMS 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. Participants in the sham TMS group receive five 20 minute Sham TMS treatment sessions per week for two weeks.

Treatment:

Device: Sham TMS