Accelerated Theta Burst in Chronic Pain: A Biomarker Study

Stanford University

Status: Withdrawn

Conditions: Chronic Pain

Treatments: Device: Intermittent Theta Burst Stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT03984201

48366

Details and patient eligibility

About

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.

Full description

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

iTBS over L-DLPFC to dACC

Active Comparator group

Description:

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.

Treatment:

Device: Intermittent Theta Burst Stimulation (iTBS)

iTBS over L-DLPFC to sgACC

Active Comparator group

Description:

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.

Treatment:

Device: Intermittent Theta Burst Stimulation (iTBS)

Sham iTBS over L-DLPFC

Sham Comparator group

Description:

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.

Treatment:

Device: Intermittent Theta Burst Stimulation (iTBS)