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Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), September 2008

Sponsors and Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Washington
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00524420
  Purpose

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.


Condition Intervention
Fibromyalgia
Chronic Pain
Depression
Device: rTMS
Device: Sham rTMS

MedlinePlus related topics:   Depression    Fibromyalgia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Widespread Pain (CWP)

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Gracely Box Intensity Rating Scale [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Measured weekly ] [ Designated as safety issue: Yes ]
  • Gracely Box Unpleasantness Scale [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
  • Neuropsychological testing [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
  • Audiometry [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Measured daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   44
Study Start Date:   February 2008
Estimated Study Completion Date:   June 2010
Estimated Primary Completion Date:   June 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active rTMS: Experimental Device: 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
Sham rTMS: Sham Comparator Device: Sham rTMS
10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 use only acetaminophen (Tylenol) for breakthrough pain
  • 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, osteoarthritis, 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
  • Ongoing opiate use
  • Involvement in litigation 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524420

Contacts
Contact: Research Coordinator     206-543-8934     tmspain@u.washington.edu    
Contact: Chandra D Wajdik, BS     206-744-2436     cwajdik@u.washington.edu    

Locations
United States, Washington
Harborview Medical Center     Recruiting
      Seattle, Washington, United States, 98104
      Principal Investigator: David H. Avery, MD            
      Sub-Investigator: Dedra Buchwald, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     David H. Avery, MD     University of Washington    
  More Information


Click here for the International Society for Transcranial Stimulation Homepage  This link exits the ClinicalTrials.gov site
 
Click here for information on University of Washington research studies that are seeking volunteers  This link exits the ClinicalTrials.gov site
 
Click here for the Neuronetics, Inc. Homepage  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   University of Washington ( David H. Avery, MD )
Study ID Numbers:   R21 AR053963, 1 R21 AR 053963-01, 06-2407-D 01
First Received:   August 30, 2007
Last Updated:   September 16, 2008
ClinicalTrials.gov Identifier:   NCT00524420
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Pain  
Fatigue  
Chronic Fatigue Syndrome  
Chronic Fatigue-Fibromyalgia Syndrome
Depression
Major Depressive Disorder

Study placed in the following topic categories:
Fatigue
Depression
Clotrimazole
Myalgic encephalomyelitis
Fibromyalgia
Myofascial Pain Syndromes
Miconazole
Tioconazole
Pain
Rheumatic Diseases
Fatigue Syndrome, Chronic
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Mood Disorders
Salicylhydroxamic acid

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Antifungal Agents
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008




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