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Procedure

iTBS for Depression

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to provide informed consent form to participate in the study

18-65 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-10 minutes

Awards & highlights

Study Summary

This trial will investigate how stimulating specific brain networks with rTMS changes network connectivity and behavior, in order to establish more effective, individualized treatments for depression.

Who is the study for?

This trial is for adults aged 18-65 who are currently experiencing a major depressive episode. It's open to those with additional anxiety or personality disorders, as long as depression is the main issue. Participants must be able to understand and agree to the study's terms.Check my eligibility

What is being tested?

The trial tests Intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation technique, on people with Major Depressive Disorder. The goal is to see how targeting specific brain networks can improve symptoms by changing network connectivity and behavior.See study design

What are the potential side effects?

While not explicitly listed here, iTBS side effects may include mild headaches or discomfort at the stimulation site, lightheadedness, or temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to understand and agree to the study's requirements.

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-10 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-10 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-10 minutes for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Applied Cognition-General Concerns scale

Blood oxygenation level dependent (BOLD) activation

Delayed Match to Sample Task

+11 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: vmPFC limbic-reward network targetExperimental Treatment1 Intervention

iTBS delivered four times daily to an individually defined reward network representation in left ventromedial prefrontal cortex (vMPFC).

Group II: dmPFC Default network B targetExperimental Treatment1 Intervention

iTBS delivered four times daily to an individually defined default network B representation in left dorsomedial prefrontal cortex (DMPFC).

Group III: DLPFC Salience network targetExperimental Treatment1 Intervention

iTBS delivered four times daily to an individually defined salience network representation in left dorsolateral prefrontal cortex (DLPFC).

Group IV: DLPFC Default network A targetExperimental Treatment1 Intervention

iTBS delivered four times daily to an individually defined default network A representation in left dorsolateral prefrontal cortex (DLPFC).

Group V: DLPFC Control network targetExperimental Treatment1 Intervention

iTBS delivered four times daily to an individually defined control network representation in left dorsolateral prefrontal cortex (DLPFC).

Group VI: SHAM stimulationPlacebo Group1 Intervention

SHAM iTBS delivered four times daily to an individually defined SHAM region in left dorsolateral prefrontal cortex (DLPFC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intermittent Theta Burst Stimulation (iTBS)

2022

N/A

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,275 Total Patients Enrolled

185 Trials studying Depression

29,556 Patients Enrolled for Depression

National Institute of Mental Health (NIMH)NIH

2,782 Previous Clinical Trials

2,689,027 Total Patients Enrolled

666 Trials studying Depression

251,434 Patients Enrolled for Depression

Media Library

Intermittent Theta Burst Stimulation (iTBS) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05523817 — N/A

Depression Research Study Groups: DLPFC Default network A target, DLPFC Control network target, SHAM stimulation, DLPFC Salience network target, dmPFC Default network B target, vmPFC limbic-reward network target

Depression Clinical Trial 2023: Intermittent Theta Burst Stimulation (iTBS) Highlights & Side Effects. Trial Name: NCT05523817 — N/A

Intermittent Theta Burst Stimulation (iTBS) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523817 — N/A

Frequently Asked Questions

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

Who is able to participate in this medical experiment?

"This clinical trial seeks to enrol 80 adults, aged 18 - 65 years old, who are suffering from major depressive disorder (MDD). Furthermore, applicants must be able to provide informed consent and they may have comorbid anxiety or personality disorders as long MDD is the primary diagnosis."

Answered by AI

Does this medical research encompass individuals older than eighty years of age?

"This clinical trial is looking for individuals between 18 and 65 years old to take part."

Answered by AI

Are there any enrollment opportunities currently available for this experiment?

"According to clinicaltrials.gov, the trial in question is not presently open for recruitment; this research was initially made available on January 2nd 2023 and last updated August 30th 2022. Despite that, 826 additional studies are still actively recruiting participants at this time."

Answered by AI

Recent research and studies

Proceedings of the National Academy of SciencesJournal

Transcranial Magnetic Stimulation Modulates the Brain's Intrinsic Activity in a Frequency-dependent Manner

Eldaief, Mark C., Mark A. Halko, Randy L. Buckner, and Alvaro Pascual-Leone. 2011. “Transcranial Magnetic Stimulation Modulates the Brain's Intrinsic Activity in a Frequency-dependent Manner”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1113103109.

NeuroImageJournal

Measuring and Manipulating Brain Connectivity with Resting State Functional Connectivity Magnetic Resonance Imaging (fcmri) and Transcranial Magnetic Stimulation (TMS)

Fox, Michael D., Mark A. Halko, Mark C. Eldaief, and Alvaro Pascual-Leone. 2012. “Measuring and Manipulating Brain Connectivity with Resting State Functional Connectivity Magnetic Resonance Imaging (fcmri) and Transcranial Magnetic Stimulation (TMS)”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2012.03.035.

clinicaltrials.govStudy

Targeting Specific Brain Networks to Treat Specific Symptoms in Depression

Mark C. Eldaief, MD 2023. "Targeting Specific Brain Networks to Treat Specific Symptoms in Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05523817.