Mini Theta Burst TMS in MDD Patients

NCT04014959 | Completed Results FDA Device

• 1 other identifier: 825761
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This is not a treatment study. In this study, the researchers are primarily interested in examining whether functional MRI (fMRI)-guided transcranial magnetic stimulation (TMS) may be more effective than traditional TMS methods at temporarily influencing neural circuit communication. The investigators test this by combining TMS and fMRI technologies to probe and modulate brain activity. If the novel fMRI-guided TMS stimulation used in this study is more effective than traditional methods, future studies may utilize similar personalized TMS targeting methods to yield even better clinical outcomes.

Conditions

Major Depressive Disorder

Keywords

depression; TMS; fMRI

Outcome Measures

Primary Outcomes (1)

• Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen

  Change in subgenual anterior cingulate evoked response (fMRI BOLD) at all four timepoints across the two TMS/fMRI scan sessions: pre-intervention and preceding a single round of iTBS in the scanner (pre-tx, pre-iTBS); pre-intervention, following single iTBS in the scanner (pre-tx, post-iTBS); post intervention, preceding iTBS in the scanner (post-tx, pre-iTBS); and post-intervention, post-iTBS in the scanner (post-tx, post-iTBS). Greater negative change is associated with more clinical improvement.

  5 days

Secondary Outcomes (1)

• Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen

  Up to one week

Other Outcomes (1)

• Change in Evoked Functional Brain Activity Before and After the 3-Day TMS Intervention Regimen

  Up to one week

Study Arms (1)

All Participants

EXPERIMENTAL

All participants follow the same procedures.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Transcranial Magnetic Stimulation (TMS) is a non-invasive form of brain stimulation. TMS can influence activity in various brain regions, and it allows researchers to test or modify brain circuit communication. Repetitive TMS (rTMS) is FDA-approved for depression treatment. TMS is administered over 5 study visits: an initial TMS/fMRI session, a 3-day TMS intervention regimen, and a post-intervention TMS/fMRI session. During TMS/fMRI sessions, participants receive single pulses of TMS pre/post a short round of Intermittent Theta Burst Stimulation (iTBS), a modified rTMS protocol. Throughout the 3-day intervention regimen, participants receive two full rounds of iTBS daily. All study participants receive active TMS.

All Participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old, inclusive
• Right-handed
• Currently experiencing a major depressive episode (MDD)
• Capacity to give informed consent and follow study procedures
• Command of English language to understand/ respond to written and verbal instructions

You may not qualify if:

• MRI contraindications (i.e., metal in body, claustrophobia, etc.)
• TMS contraindications (i.e., seizure disorder)
• Current use of psychiatric medication and unable/ willing to safely withdraw
• Refusal to abstain from alcohol or drugs for duration of study
• Medication use that reduces seizure threshold
• Medication that interferes with blood flow (i.e., opioids, antihypertensive)
• Known neurological disorder or significant disability that interferes with study procedures
• Woman who is pregnant or breastfeeding

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Bossus L, Dickson J, Blaine C, Khalilkhani H, Khan A, Oathes DJ. Causal connectivity maps derived from single-pulse interleaved TMS/fMRI. Sci Rep. 2026 Jan 22;16(1):3070. doi: 10.1038/s41598-025-23684-7.

  PMID: 41571696 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Desmond Oathes, Principal Investigator
• Organization: University of Pennsylvania

oathes@pennmedicine.upenn.edu

215-573-9390

Study Officials

• Desmond Oathes, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: All subjects receive active TMS to their individualized fMRI-guided target. Participants will first receive TMS in the MRI scanner, then over the course of 3-Day TMS Intervention Regimen, and lastly in a final MRI scan.

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 10, 2019
• Study Start: July 14, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: April 2, 2024
• Results First Posted: April 2, 2024

Record last verified: 2024-03

Locations

US (1)