Mini Theta Burst TMS in MDD Patients (NARSAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04014959|
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 10, 2019
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|
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 (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|
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.
- 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
- 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
- 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
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
|Contact: Hannah Longemail@example.com|
|Contact: Center for Neuromodulation in Depression and Stressfirstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|