Personalized Neuromodulation for Treatment-Resistant Depression

Overseen By Jade T Truong, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Antidepressants

Disqualifiers: Other psychiatric diagnosis, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 hours per testing day

What You Need to Know Before You Apply

What is the purpose of this trial?

This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.

Who Is on the Research Team?

Corey J Keller, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am currently experiencing moderate to severe depression.

Able to comprehend English sufficiently to complete study procedures and assessments

I am between 18 and 65 years old.

Exclusion Criteria

High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

Primary psychiatric diagnosis other than MDD

Contraindications to MRI (e.g., implanted metal)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to approximately 3 weeks

3 screening days

Treatment

Participants receive 10 sessions of iTBS using either personalized or non-personalized settings, or sham iTBS

10 hours per testing day

10 sessions

Follow-up

Participants are monitored for changes in depression and anxiety symptoms, as well as cognitive performance

Up to approximately 7 weeks

End of each testing day

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Theta Burst Stimulation (iTBS)

How Is the Trial Designed?

Group I: Personalized iTBS Experimental Treatment 1 Intervention

Participants receive 10 sessions of iTBS using individually selected pulse count and intensity parameters identified during a prior screening phase as producing the greatest suppression of the EL-TEP biomarker.

Group II: Non-Personalized iTBS Active Control 1 Intervention

Participants receive 10 sessions of iTBS using standard fixed parameters (1800 pulses, 120% resting motor threshold).

Group III: Sham iTBS Placebo Group 1 Intervention

Participants receive 10 sessions of sham iTBS, matched in timing and scalp sensation to active stimulation using a shielded coil and scalp electrodes.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+