Accelerated Theta Burst in Chronic Pain: A Biomarker Study
NCT ID: NCT03984201
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-06-01
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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iTBS over L-DLPFC to dACC
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.
Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
iTBS over L-DLPFC to sgACC
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.
Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Sham iTBS over L-DLPFC
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.
Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Interventions
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Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Nolan R
Assistant Professor of Psychiatry and Behavioral Sciences
Locations
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Stanford University
Palo Alto, California, United States
Countries
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References
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Other Identifiers
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48366
Identifier Type: -
Identifier Source: org_study_id