Engaging sgACC With TMS for Depression

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder; Depression; Persistent Depressive Disorder
• Interventions: Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT06266390
• Lead Sponsor: University of Pennsylvania

Brief Summary

The purpose of this study is to investigate the responses of the brain region known as the subgenual anterior cingulate cortex (sgACC) during transcranial magnetic stimulation (TMS) in individuals with depression. Specifically, investigators aim to determine whether the sgACC is engaged when TMS is delivered to specific targets and if the engagement of sgACC changes throughout a full TMS treatment intervention. To achieve this goal, the investigators will employ a combination of TMS and Magnetic Resonance Imaging (MRI) procedures.

Study participation will include completing various questionnaires, clinical assessments, receiving a full transcranial magnetic stimulation (TMS) treatment intervention (every weekday for 4-6 weeks), and undergoing MRI scans, both with and without concurrent TMS.

Detailed Description

Interested subjects will be asked to complete multiple questionnaires, a clinical interview, and a TMS demonstration to determine eligibility following the informed consent process.

If determined eligible, participants will proceed to undergo an MRI scan to generate their individualized TMS targets.The subsequent visit will involve the first MRI scanning session with concurrent TMS (TMS/fMRI), referred to as Baseline TMS/fMRI, along with the completion of multiple questionnaires.

Following the Baseline TMS/fMRI session, participants will begin the TMS treatment phase. This phase comprises daily sessions (Monday to Friday) lasting 4-6 weeks, during which participants will receive rTMS treatments and complete various surveys.

Midway through and upon completion of the TMS treatment intervention, two additional TMS/fMRI sessions will replicate the procedures conducted during the initial Baseline TMS/fMRI.

Remote follow-up assessments at 1, 6, and 12 months post-treatment will evaluate any enduring improvements in clinical symptoms.

Participants will be compensated for completing study procedures.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Study Start: 2024-05-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-12
• Last Update Posted: 2024-06-14
• Primary Completion: 2026-01-30
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Correlation Target	Transcranial Magnetic Stimulation (TMS)	TMS treatment will be administered using a TMS target positively correlated with the sgACC.
Anticorrelation Target	Transcranial Magnetic Stimulation (TMS)	TMS treatment will be administered using a TMS target anticorrelated with the sgACC.

Primary Outcome Measures

Name	Time	Method
sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off)	Single visit (~2 hours)	This primary endpoint aims to directly assess sgACC engagement during fMRI-guided TMS by comparing sgACC BOLD signal under TMS On and TMS Off conditions. This sgACC BOLD signal change will be defined as sgACC evoked response henceforth.

Secondary Outcome Measures

Name	Time	Method
Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets	Up to 7 weeks	Test the efficacy of positive and negative functionally connected (FC) targets in inducing changes in sgACC evoked response (modulation) before and after TMS treatment.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States