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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment

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.

0 / 5Eligibility criteria met