Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Chronic Pain
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Repetitive Transcranial Magnetic Stimulation (rTMS), Accelerated Theta Burst Stimulation (aTBS), Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
Eligibility Criteria
Inclusion Criteria:
- 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)
- Age 18 - 70
- Right-handed
- Agree to having fMRI scans as well as rTMS sessions
- Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
- Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
- 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:
- History of MI, CABG, CHF, or other cardiac history.
- Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
- Pregnancy or breastfeeding
- 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.
- Autism spectrum disorder
- Inability to stop taking medication contraindicated with treatment
- Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
- A positive urine toxicology screen
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
iTBS over L-DLPFC to dACC
iTBS over L-DLPFC to sgACC
Sham iTBS over L-DLPFC
Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the dorsal anterior cingulate cortex (dACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.
Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the subgenual cingulate cortex (sgACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance. Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.
Participants will receive sham iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Sham stimulation will be delivered to L-DLPFC using the MagPRo stimulator.