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Accelerated Theta Burst in Chronic Pain: A Biomarker Study
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.
Conditions:
🦠 Chronic Pain
🗓️ Study Start (Actual) June 2023
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) August 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Palo Alto, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
    • 2. Age 18 - 70
    • 3. Right-handed
    • 4. Agree to having fMRI scans as well as rTMS sessions
    • 5. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
    • 6. Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
    • 7. Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.

    Exclusion Criteria:

    • 1. History of MI, CABG, CHF, or other cardiac history.
    • 2. Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
    • 3. Pregnancy or breastfeeding
    • 4. Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
    • 5. Autism spectrum disorder
    • 6. Inability to stop taking medication contraindicated with treatment
    • 7. Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
    • 8. A positive urine toxicology screen
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 May 2019
  • First Submitted that Met QC Criteria 11 June 2019
  • First Posted 12 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 May 2022
  • Last Update Posted 6 May 2022
  • Last Verified May 2022