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

NCT ID: NCT00523302

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-11-30

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.

Conditions

Major Depression; Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active TMS

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.

Group Type: ACTIVE_COMPARATOR

Active TMS

Intervention Type: DEVICE

Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.

Sham TMS

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.

Group Type: SHAM_COMPARATOR

Sham TMS

Intervention Type: DEVICE

Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.

Interventions

Active TMS

Active TMS uses the active TMS coil to stimulate the cortical area of interest. Active TMS involves 80 trains x 15 sec = 4000 pulses per session, 5 x per week= 20,000 pulses per week, x 2 weeks = 40,000 pulses.

Intervention Type: DEVICE

Sham TMS

Sham TMS uses the same stimulation frequency as the Active TMS but uses the Sham TMS coil instead to prevent actual stimulation from occurring (chosen as a priori stimulation based on studies showing antidepressant and anti-nociceptive effects): 10 Hertz - Pulse train duration (on time) 5 seconds, Power (intensity) level 120% of stored motor threshold, Inter-train interval (off time) 10 seconds (15 second cycle time). Additionally, stimulation-train duration and inter-stimulus intervals were determined such that they are in compliance with current published rTMS safety guidelines.

Intervention Type: DEVICE

Other Intervention Names

Neotonus model 2100 xxx; Neotonus model 2100 xxx

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward B Short, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21764215 (View on PubMed)

Other Identifiers

AR049459

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HR#17365

Identifier Type: -

Identifier Source: org_study_id