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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment, immediately post-treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Brief Pain Inventory (BPI) score

Change in the McGill Pain Questionnaire score

Secondary outcome measures

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 / 3Eligibility criteria met

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,386 Previous Clinical Trials

17,333,948 Total Patients Enrolled

36 Trials studying Chronic Pain

9,173 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an upper age limit for participation?

"As specified in the stated eligibility requirements, no individual below 18 years old or above 70 can partake in this trial."

Answered by AI

Are there currently opportunities to join the clinical trial?

"According to clinicaltrials.gov, this specific medical trial is closed for recruitment at the moment. This investigation was first posted on June 1st 2023 and last updated on May 4th 2022 - but don't worry! Presently there are 403 other trials recruiting participants."

Answered by AI

Is it possible to sign up for this medical experiment?

"Sixty eligible individuals, aged between 18 and 70, with chronic pain shall be accepted to this trial. Entry criteria necessitate a minimum score of 4/10 on the clinical pain rating scale or fulfilment of fibromyalgia diagnostic criteria from 2010 (Wolfe et al., 2010). Moreover, only right-handed participants may join; if already taking antidepressants they must have been stable for 6 weeks prior while being restricted to SSRIs throughout the study period."

Answered by AI

What is the objective of this scientific investigation?

"The trial will track the McGill Pain Questionnaire score to measure primary outcomes pre-treatment and post-treatment. Secondary outcomes include changes in Pain Catastrophizing Scale (PCS) ratings, functional connectivity as observed via Functional Magnetic Resonance Imaging (fMRI), and Montgomery Asberg Depression Rating Scale (MADRS) results."

Answered by AI

Recent research and studies

Neurophysiologie Clinique/Clinical NeurophysiologyJournal

The Use of Repetitive Transcranial Magnetic Stimulation (rtms) in Chronic Neuropathic Pain

Lefaucheur, J.P.. 2006. “The Use of Repetitive Transcranial Magnetic Stimulation (rtms) in Chronic Neuropathic Pain”. Neurophysiologie Clinique/clinical Neurophysiology. Elsevier BV. doi:10.1016/j.neucli.2006.08.002.

The Journal of ECTJournal

Transcranial Magnetic Stimulation in the Treatment of Chronic Widespread Pain

Avery, David H., Paul Zarkowski, Daniel Krashin, Wang-ku Rho, Chandra Wajdik, Jutta M. Joesch, David R. Haynor, Dedra Buchwald, and Peter Roy-Byrne. 2015. “Transcranial Magnetic Stimulation in the Treatment of Chronic Widespread Pain”. The Journal of ECT. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/yct.0000000000000125.

Brain StimulationJournal

The Impact of Accelerated Hf-rtms on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights from 18FDG PET Brain Imaging

Baeken, Chris, Daniele Marinazzo, Hendrik Everaert, Guo-Rong Wu, Christian Van Hove, Kurt Audenaert, Ingeborg Goethals, Filip De Vos, Kathelijne Peremans, and Rudi De Raedt. 2015. “The Impact of Accelerated Hf-rtms on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights from 18FDG PET Brain Imaging”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2015.01.415.

Current Opinion in PsychiatryJournal