Mini Theta Burst TMS in MDD Patients

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT04014959
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

This study will involve a baseline Magnetic Resonance Imaging (MRI) scan, Transcranial Magnetic Stimulation (TMS), and TMS interleaved with functional MRI (fMRI) scans.

After screening, eligible participants will undergo a 1-hour MRI scan, encompassing structural and functional scans to establish TMS stimulation targets for subsequent visits. During the baseline TMS/fMRI session or pre-intervention TMS/fMRI, single pulses of TMS and a short round of repetitive TMS (rTMS) will be administered to the participant's individualized target while functional MRI scans (fMRI) are collected. Following this, participants will commence a short TMS intervention regimen involving daily rTMS over 3 consecutive days. The day after the intervention, participants will undergo another TMS/fMRI session, or the post-intervention TMS/fMRI, to capture potential changes from the 3-day intervention.

Clinical assessments will be conducted at baseline before the first TMS/fMRI session and again after the final TMS/fMRI session to assess symptom changes.

Study Timeline

• Study Start: 2017-07-14
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-08
• Study First Posted: 2019-07-10
• Primary Completion: 2020-06-30
• Study Completion: 2021-06-30
• Results First Submitted: 2022-05-19
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Results First Posted: 2024-04-02
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• 18 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

Read More

Exclusion Criteria

• MRI contraindications (i.e., metal in body, claustrophobia, etc.)
• TMS contraindications (i.e., seizure disorder)
• Diagnosis of exclusionary psychiatric disorder (i.e., schizophrenia, bipolar)
• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Transcranial Magnetic Stimulation	All participants follow the same procedures.

Primary Outcome Measures

Name	Time	Method
Changes in Evoked Functional Brain Activity Pre/Post Short iTBS Stimulation Before and After the 3-Day TMS Intervention Regimen	5 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in Depression, Anxiety and Stress Scale (DASS-21) Score Pre/Post the 3-Day TMS Intervention Regimen	Up to one week	The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report tool with 21 items, assessing depression, anxiety, and stress levels. The scale scores range from 0 to 63, with higher scores indicating more severe or frequent emotional symptoms. The change in DASS-21 score will be evaluated pre and post the 3-day TMS Intervention Regimen.

Trial Locations

Locations (1)

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