Depression Clinical Trial
Official title:
Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Widespread Pain (CWP)
Verified date | April 2013 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Harborview Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Gracely Box Unpleasantness Scale | The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS. | Measured weekly | Yes |
Secondary | Hamilton Depression Rating Scale | The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal. | Measured weekly | Yes |
Secondary | Adverse Events | Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit. | Measured daily | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A |