Transcranial Magnetic Stimulation for Major Depressive Disorder

(rmPFC-Savoring Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Neurological disorders, Brain devices, Pregnancy, others

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a non-invasive brain stimulation and neuroimaging study that will examine how activity in the medial prefrontal cortex influences reward processing, particularly positive savoring, in individuals with depression. The central question is whether modulating medial prefrontal brain regions using transcranial magnetic stimulation (TMS) alters neural and behavioral responses to rewards. Brain activity will be recorded using both electroencephalography (EEG) and functional magnetic resonance imaging (fMRI) while participants perform reward tasks. The primary objectives are to (1) identify patterns of brain activity linked to impaired reward processing in depression using EEG and fMRI, and (2) determine the causal role of specific prefrontal areas in these processes through targeted TMS. The methods include four sessions over four weeks: a clinical assessment, EEG recording during reward tasks after participants learn/practice positive savoring, an fMRI session, and a TMS session combined with EEG while participants practice positive savoring and perform reward tasks during EEG.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 65 years old.

* Willing to comply with all study procedures and be available for the duration of the study

* Acceptable suicide risk as determined by less than 5 on the Depression Symptom Index Suicidality Subscale (DSI-SS)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Clinical Assessment

Participants undergo a clinical assessment to establish baseline measures

1 week

1 visit (in-person)

EEG Recording

EEG recording during reward tasks after participants learn/practice positive savoring

1 week

1 visit (in-person)

fMRI Session

Participants undergo an fMRI session to record brain activity

1 week

1 visit (in-person)

TMS Session

TMS session combined with EEG while participants practice positive savoring and perform reward tasks

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in neural and behavioral responses to rewards

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Intermittent Theta Burst Transcranial Magnetic Stimulation

How Is the Trial Designed?

Group I: Left Rostromedial Prefrontal Cortex - Accelerated Intermittent Theta Burst Experimental Treatment 1 Intervention

Accelerated intermittent theta burst will be delivered to left rostromedial prefrontal cortex, which has been previously shown to manipulate reward sensitivity. We are testing if this also impacts positive savoring as measured by the late positive potential during EEG and positive affect. This is an experimental condition that will be compared to an active comparator and a sham comparator.

Group II: Left Dorsolateral Prefrontal Cortex - Accelerated Intermittent Theta Burst Active Control 1 Intervention

Accelerated intermittent theta burst will be delivered to left dorsolateral prefrontal cortex, which is considered "treatment as usual" for depression.

Group III: Left Primary Somatosensory Cortex - Accelerated Intermittent Theta Burst Placebo Group 1 Intervention

Accelerated intermittent theta burst will be delivered to left primary somatosensory cortex, which is a placebo intervention condition.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+