Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

NCT00524420 | Completed Phase 2 Results DMC

• 4 other identifiers: 32656-DR21AR0539631R21AR053963-0106-2407-D 01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Pain; Depression

Keywords

Pain; Fatigue; Chronic Fatigue Syndrome; Chronic Fatigue-Fibromyalgia Syndrome; Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Gracely Box Intensity Rating Scale

  The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.

  Measured weekly

Secondary Outcomes (3)

• Gracely Box Unpleasantness Scale

  Measured weekly

• Hamilton Depression Rating Scale

  Measured weekly

• Adverse Events

  Measured daily

Study Arms (2)

Active rTMS

EXPERIMENTAL

Active rTMS involves administration of real rTMS to the patient.

Device: rTMS

Sham rTMS

SHAM COMPARATOR

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

Device: Sham rTMS

Interventions

rTMS 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

Also known as: Neuronetics 2100 CRS rTMS System

Active rTMS

Sham rTMS DEVICE

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

Also known as: Neuronetics 2100 rTMS and James Long Integrated Sham System

Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 17502802 BACKGROUND

Related Links

• Click here for the Neuronetics, Inc. Homepage

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Depression; Pain; Fatigue; Fatigue Syndrome, Chronic; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Encephalomyelitis; Neuroinflammatory Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: David H. Avery, MD, Professor
• Organization: University of Washington

averydh@u.washington.edu

206-744-4527

Study Officials

• David H. Avery, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: September 3, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 23, 2013
• Results First Posted: May 23, 2013

Record last verified: 2013-04

Locations

US (1)