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Mini Theta Burst TMS in MDD Patients (NARSAD)

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ClinicalTrials.gov Identifier: NCT04014959
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Desmond Oathes, 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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Combination Product: TMS/ fMRI Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects receive active TMS to the novel fMRI-guided targeting site. Participants will first receive TMS in the MRI scanner, then over the course of three consecutive "mini TMS" days, and lastly in a final MRI scan.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mini Theta Burst TMS to Promote Brain Plasticity Indexed by fMRI in MDD Patients
Actual Study Start Date : July 14, 2017
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Evoked response (change in functional brain activity) to TMS measured using fMRI [ Time Frame: Baseline, immediately ]
    Evoked response (change in functional brain activity) to TMS performed at an fMRI-guided brain target, measured using fMRI


Secondary Outcome Measures :
  1. Changes in evoked functional brain activity after the 3 day "mini-TMS" stimulation regimen [ Time Frame: One week ]
    Evoked functional brain activity to TMS, compared from the baseline fMRI scan to the final fMRI scan following the three day mini-TMS stimulation

  2. Correlation of changes in MDD symptoms and evoked brain response to TMS [ Time Frame: One week ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014959


Contacts
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Contact: Hannah Long 215-746-0295 hanlong@pennmedicine.upenn.edu
Contact: Center for Neuromodulation in Depression and Stress 215-746-2637 cndslab@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania

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Responsible Party: Desmond Oathes, Assistant Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04014959     History of Changes
Other Study ID Numbers: 825761
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Desmond Oathes, University of Pennsylvania:
depression
TMS
fMRI

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms