Clinical trial NCT00523302: A Pilot Study of TMS Effects on Pain and Depression in Patients With Fibromyalgia
Official title: A Pilot Study of Transcranial Magnetic Stimulation (TMS) Effects on Pain and Depression in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Fibromyalgia
Keywords: Major Depression
Fibromyalgia
TMS
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-08-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average Pain
timeFrame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
measure: THE FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ)-Modified
timeFrame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
measure: THE HAMILTON DEPRESSION RATING SCALE (HRDS)
timeFrame: Baseline, After Week 1 of Treatment, After Week 2 of Treatment, One week Post Treatment follow up, and Two week post treatment follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Edward B Short, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Short BE, Borckardt JJ, Anderson BS, Frohman H, Beam W, Reeves ST, George MS. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: a randomized, controlled pilot study. Pain. 2011 Nov;152(11):2477-2484. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.