Clinical trial NCT03984201: Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Official title: Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Repetitive Transcranial Magnetic Stimulation (rTMS)
Accelerated Theta Burst Stimulation (aTBS)
Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, randomized control
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Brief Pain Inventory (BPI) score
timeFrame: Pre-treatment, immediately post-treatment
measure: Change in the McGill Pain Questionnaire score
timeFrame: Pre-treatment, immediately post-treatment
Secondary outcomes:
measure: Change in the Montgomery Asberg Depression Rating Scale (MADRS) score
timeFrame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
measure: Change in teh Hamilton Rating Scale for Depression (HAM-17) score
timeFrame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
measure: Change in the Pain Catastrophizing Scale (PCS) score
timeFrame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
measure: Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Pre-treatment, immediately post-treatment, 4 weeks post-treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
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