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Procedure

iTBS for Depression

N/A
Recruiting
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

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.
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.
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
Select...
I am able to understand and agree to the study's requirements.
Select...
I am between 18 and 65 years old.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
~20

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,308,940 Total Patients Enrolled
192 Trials studying Depression
33,942 Patients Enrolled for Depression
National Institute of Mental Health (NIMH)NIH
2,913 Previous Clinical Trials
2,738,455 Total Patients Enrolled
700 Trials studying Depression
260,931 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
~53 spots leftby Dec 2027
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