Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

NCT ID: NCT00524420

Last Updated: 2013-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-12-31

Brief Summary

While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of time, chronic pain persists and can continue for months and even years. Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the brain and can affect brain activity. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing chronic widespread pain in women.

Detailed Description

Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3 months, pain above and below the waist, pain on both the right and left sides, and pain in the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a hallmark feature of fibromyalgia. Significant physical and emotional effects usually accompany chronic widespread pain and fibromyalgia, making the development of effective treatments a priority. rTMS involves a neurophysiologic technique that directs a current into the brain by using a magnetic field to pass the scalp and skull safely and painlessly. Stimuli are applied to the same brain area several times per second during several consecutive seconds. rTMS has been found to be effective for treating certain types of chronic pain. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing bodily pain associated with chronic widespread pain and/or fibromyalgia in women.

Participants in this study will undergo a diagnostic interview, physical and neurological exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for screening purposes. Eligible participants will then be randomly assigned to receive either rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15 days. After every five treatment sessions, participants will be interviewed about their pain and depression symptoms, and they will fill out questionnaires about pain, depression, fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance testing of their right thumb. On a daily basis, participants will rate their level of pain using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment and will include a repeat interview and testing. After the follow-up evaluations, any participants who did not respond to the sham treatment will be offered a series of 15 real rTMS treatment sessions.

Conditions

Fibromyalgia; Chronic Pain; Depression

Study Design

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

Study Groups

Active rTMS

Active rTMS involves administration of real rTMS to the patient.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex

Sham rTMS

Sham rTMS is a placebo or inactive form of rTMS for study control and comparison purposes.

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS

Interventions

rTMS

10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex

Intervention Type: DEVICE

Sham rTMS

10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS

Intervention Type: DEVICE

Other Intervention Names

Neuronetics 2100 CRS rTMS System; Neuronetics 2100 rTMS and James Long Integrated Sham System

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic widespread pain as defined by the 1990 American College of Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain above and below the waist; pain on both right and left sides; pain at one axial site (e.g., head, neck, spine, or back)
• Willing to remain on a stable medical regimen during the entire 6-week course of Phase 1 treatment and 8 weeks prior to rTMS treatment
• Willing to undergo random assignment and able to attend treatment sessions
• Willing to remain on a stable psychotherapy regimen if currently receiving psychotherapy that has been ongoing for at least 3 months prior to study entry

Exclusion Criteria

• Unable to maintain treatment as usual at stable doses for any medical or psychiatric conditions for 8 weeks prior to and during the study
• Another medical condition associated with significant pain (e.g., diabetic neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease)
• Any condition that might increase the risk of seizures from TMS
• History of a seizure disorder or family history of a seizure disorder
• Previous use of TMS
• Involvement in litigation or disability that is related to fibromyalgia, chronic widespread pain, or depression
• Current use of proconvulsant medications (e.g., bupropion)
• Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g., aneurysm clips, pacemakers, neurostimulators)
• History of head injury associated with loss of consciousness for more than 15 minutes, brain surgery, or lithium toxicity
• History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic disorder, or post-traumatic stress disorder
• Current substance abuse or dependence
• Active suicidal intent or plan
• Severe claustrophobia that would prevent MRI
• Major depression with psychotic features or a current major depressive episode lasting longer than 5 years
• Pregnant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

David Avery

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David H. Avery, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

Avery DH, Holtzheimer PE 3rd, Fawaz W, Russo J, Neumaier J, Dunner DL, Haynor DR, Claypoole KH, Wajdik C, Roy-Byrne P. Transcranial magnetic stimulation reduces pain in patients with major depression: a sham-controlled study. J Nerv Ment Dis. 2007 May;195(5):378-81. doi: 10.1097/NMD.0b013e31802f58d1.

Reference Type: BACKGROUND

PMID: 17502802 (View on PubMed)

Related Links

http://www.neuronetics.com/

Click here for the Neuronetics, Inc. Homepage

Other Identifiers

R21AR053963

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R21AR053963-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-2407-D 01

Identifier Type: OTHER

Identifier Source: secondary_id

32656-D

Identifier Type: -

Identifier Source: org_study_id