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Completed

NCT Number: NCT04014959

Mini Theta Burst TMS 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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Other outcomes

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

    Time frame: Up to one week

    Change in subgenual anterior cingulate evoked response (fMRI BOLD) Before and After the 3-Day TMS Intervention Regimen

    Greater negative change is associated with more clinical improvement.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: NARSAD

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jul 10, 2019
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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