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

Completed · Not applicable · Has a placebo group

Conditions studied: Major Depression, Fibromyalgia

In brief

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.

Key facts

Study ID

NCT00523302

Run by

Medical University of South Carolina

People needed

20

Starts

2007-07-01

Expected to finish

2009-11-01

Last updated by the study team

2018-07-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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