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Non-invasive Brain Stimulation

Theta Burst Stimulation for Chronic Pain

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 70
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.
Must not have
Inability to stop taking medication contraindicated with treatment
History of MI, CABG, CHF, or other cardiac history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, immediately post-treatment
Awards & highlights

Summary

This trial is testing a new, accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device to see if it can help with chronic pain. The trial is double blind, meaning neither the participants nor the researchers will know who is receiving the treatment until after the trial is over. All participants will be offered the chance to receive the active treatment 4 weeks before the trial is completed.

Who is the study for?
This trial is for adults aged 18-70 with chronic pain, scoring at least 4/10 on a pain scale or meeting fibromyalgia criteria. Participants must be right-handed, not pregnant, agree to use contraception if applicable, and can only take SSRIs if on antidepressants. They must understand English and consent to MRI scans and rTMS sessions.
What is being tested?
The study tests an accelerated schedule of theta-burst stimulation (iTBS) using transcranial magnetic stimulation for chronic pain relief. It's a double-blind study where participants are randomly assigned to receive iTBS or placebo before all get the active treatment.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Since it involves magnetic fields, there might also be risks related to disturbances in metal devices within the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have been on a stable SSRI antidepressant for at least 6 weeks.
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I experience significant pain or meet the criteria for fibromyalgia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot stop taking a medication that conflicts with the trial treatment.
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I have a history of heart issues, including heart attack or heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Brief Pain Inventory (BPI) score
Change in the McGill Pain Questionnaire score
Secondary study objectives
Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI)
Change in teh Hamilton Rating Scale for Depression (HAM-17) score
Change in the Montgomery Asberg Depression Rating Scale (MADRS) score
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: iTBS over L-DLPFC to dACCActive Control1 Intervention
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.
Group II: iTBS over L-DLPFC to sgACCActive Control1 Intervention
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.
Group III: Sham iTBS over L-DLPFCPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,334 Total Patients Enrolled
38 Trials studying Chronic Pain
9,288 Patients Enrolled for Chronic Pain

Media Library

Intermittent Theta Burst Stimulation (iTBS) (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03984201 — N/A
Chronic Pain Research Study Groups: iTBS over L-DLPFC to dACC, iTBS over L-DLPFC to sgACC, Sham iTBS over L-DLPFC
Chronic Pain Clinical Trial 2023: Intermittent Theta Burst Stimulation (iTBS) Highlights & Side Effects. Trial Name: NCT03984201 — N/A
Intermittent Theta Burst Stimulation (iTBS) (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03984201 — N/A
~27 spots leftby Sep 2025
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