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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00523302
First received: August 30, 2007
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Major Depression
Fibromyalgia
Device: Neotonus model 2100 xxx

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • The Brief Pain Inventory
  • The McGill Pain Questionnaire
  • Fibromyalgia Impact Questionnaire
  • Fibromyalgia Health Assesment Questionnaire

Secondary Outcome Measures:
  • The Beck Depression Inventory
  • The Hamilton Depression Rating Scale
  • Alteration in acute and chronic changes in IL-1, IL-6, IL-8

Estimated Enrollment: 20
Study Start Date: July 2007
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523302

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: E. Baron Short, MD Medical University of South Carolina
  More Information

No publications provided by Medical University of South Carolina

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00523302     History of Changes
Other Study ID Numbers: HR#17365, SPID 0793
Study First Received: August 30, 2007
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Major Depression
Fibromyalgia
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Fibromyalgia
Myofascial Pain Syndromes
Behavioral Symptoms
Mental Disorders
Mood Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 29, 2014