Mini Theta Burst TMS in MDD Patients (NARSAD)

Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI in MDD Patients

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Combination product: TMS/ fMRI Stimulation

Detailed Description

Non-invasive transcranial magnetic stimulation (TMS) is now FDA-approved for the treatment of major depressive disorder (MDD). However, there is growing evidence that the targeting strategy for delivering TMS treatment may yield superior clinical outcomes if it is tailored to individual neuroanatomy. In this observational study, the investigators plan to examine this theory by using individualized TMS targets created from participants' own fMRI scans.

This is not a treatment study, and stimulation is not designed to provide treatment in this study. Instead, the TMS delivery is meant to temporarily modify brain circuit communication between the lateral prefrontal cortex and subcortical structures. The research team administers TMS inside of the MRI scanner to prove that this pathway can be influenced non-invasively with TMS.

These subcortical structures are important to affective disorder, and may contribute to the symptoms that patients suffering from depression are experiencing. The researchers hope that this innovative TMS research will confirm neural networks important to affective disorders, and guide future treatment options.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: All Participants; All participants follow the same procedures.	Combination product: TMS/ fMRI Stimulation; The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three "mini TMS" sessions, and a final TMS/ fMRI scan. Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evoked response (change in functional brain activity) to TMS measured using fMRI	Evoked response (change in functional brain activity) to TMS performed at an fMRI-guided brain target, measured using fMRI	Baseline, immediately

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in evoked functional brain activity after the 3 day "mini-TMS" stimulation regimen	Evoked functional brain activity to TMS, compared from the baseline fMRI scan to the final fMRI scan following the three day mini-TMS stimulation	One week
Correlation of changes in MDD symptoms and evoked brain response to TMS	Correlation of change in MDD symptoms from baseline to final fMRI visit, and change in evoked brain response to TMS from baseline to final fMRI scan	One week

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 14, 2017
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (ACTUAL): July 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: depression; fMRI; TMS
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 825761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No