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Neuromodulation

rTMS for Depression

N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No seizure disorder or risk of seizures
No current or history of neurological disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 hours
Awards & highlights

Study Summary

This trial will test whether a technique called repetitive transcranial magnetic stimulation (rTMS) is more effective when targeting the dorsolateral prefrontal cortex (dlPFC) of the central executive network (CEN).

Who is the study for?
This trial is for adults aged 18-65 with major depression, as confirmed by a clinical interview. Participants must understand English, have no seizure risk or neurological disorders, not be using certain medications or substances, and not be pregnant. They should also have a significant level of depression severity.Check my eligibility
What is being tested?
The study tests whether personalized rTMS targeting the central executive network can better improve symptoms in those with depression compared to standard approaches. It's a randomized and double-blind experiment involving different types of rTMS including sham (placebo) treatment.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or temporary hearing changes due to the noise during treatment. Rarely it could induce seizures but precautions are taken to minimize this risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have seizures or a risk of having them.
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I have no history of neurological disorders.
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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Transcranial Magnetic Stimulation (TMS) / Electroencephalography (EEG) change

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Individualized CEN-targeted rTMSExperimental Treatment2 Interventions
Individualized CEN-targeted rTMS will combine neuronavigated rTMS and single pulse TMS-EEG to identify the region of the dlPFC making the strongest connection with the parietal node of the CEN. First, regions of the dlPFC strongly connected to the parietal CEN will be identified by applying single TMS pulses in grid-like fashion to ROIs within the dlPFC. For each anatomical dlPFC subunit probed with TMS, the TMS-EEG response will be quantified in the parietal region of the CEN. The dlPFC subunit that demonstrates the strongest TMS-EEG response in parietal cortex will be chosen for rTMS. rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS session for adverse events and/or side effects.
Group II: Neuronavigated rTMSActive Control2 Interventions
Neuronavigated rTMS will be delivered using neuro-navigation based on participants' own MRI images to target the dlPFC. rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS session for adverse events and/or side effects.
Group III: Scalp-targeted rTMSActive Control2 Interventions
Scalp-targeted rTMS will be delivered using standard BEAM F3 targeting methodology to target the dlPFC. rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the rTMS session for adverse events and/or side effects.
Group IV: Sham rTMSPlacebo Group1 Intervention
Sham rTMS will be delivered for one session to mimic active rTMS conditions. To maximize sham validity, both 1) a direction- sensor TMS coil will alert the operators to flip the coil if the wrong side is being used, and 2) low-intensity electrical stimulation to match the active rTMS frequency will be applied to scalp electrodes under the coil for sham and placed but not activated in the active arm. The rTMS coil will be positioned using neuro-navigation based on participants' own MRI images, mimicking active rTMS. Sham rTMS will last approximately 30 minutes (3000 pulses total) and will be delivered at 120% of the participant's motor threshold. Participants will be monitored during the sham rTMS session for adverse events and/or side effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham rTMS
2008
Completed Phase 3
~1020

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,570 Total Patients Enrolled
107 Trials studying Depression
93,884 Patients Enrolled for Depression

Media Library

Individualized CEN-targeted rTMS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05224063 — N/A
Depression Research Study Groups: Individualized CEN-targeted rTMS, Neuronavigated rTMS, Scalp-targeted rTMS, Sham rTMS
Depression Clinical Trial 2023: Individualized CEN-targeted rTMS Highlights & Side Effects. Trial Name: NCT05224063 — N/A
Individualized CEN-targeted rTMS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224063 — N/A

Frequently Asked Questions

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

What criteria must prospective participants meet in order to qualify for this research?

"This clinical research is seeking 50 individuals over the age of majority and below 65 years old who currently have major depressive disorder (MDD). Eligible applicants must also meet the following requirements: male or female, SCID-I administered for depression diagnosis, PHQ9 score greater than 10 demonstrating sickness gravity, English fluency to understand EEG/TMS instructions and tests scales correctly; right handedness; absence of neurological illnesses in history or present times; no seizure disorders nor risk thereof; no PRN medication use within previous 24 hours from scheduled study appointment."

Answered by AI

Are there opportunities currently available to enroll in this research project?

"As of this moment, clinicaltrials.gov lists this trial as inactive - it was first published on January 1st 2023 and last updated on the 31st of January 2022. However, there are 828 other trials that are currently looking to enrol patients into their studies."

Answered by AI

Are people aged 40 or above eligible to join the experimental research?

"This research project is looking for individuals aged 18 to 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neuromodulation in Depression
Corey Keller 2023. "Probing the Dorsolateral Prefrontal Cortex and Central Executive Network for Improving Neuromodulation in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224063.
~24 spots leftby Jun 2025
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