- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06274112
Using TMS to Understand Neural Processes of Social Motivation
Personalized Neuromodulation Targeting Dysregulated Motivational Responses Underlying Social Avoidance Behavior
The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation.
Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks.
Adults in the Auburn/Opelika area and surrounding areas who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36849
- Recruiting
- Auburn University
-
Contact:
- Travis Evans, PhD
- Phone Number: 3348444550
- Email: tce0018@auburn.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A diagnosis of Major Depressive Disorder OR a diagnosis of Social Anxiety Disorder (assessed/confirmed at screening visit).
- Scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at phone screen).
Exclusion Criteria:
- Unstable psychotropic medication regimen (i.e., changes in psychotropic medication or dosage in past 3 months).
- Current or lifetime diagnosis of Bipolar Disorder.
- A diagnosis of substance use disorder within past 12 months.
- A diagnosis of psychotic-spectrum disorder such as Schizophrenia.
- Pregnancy or probable pregnancy.
- Medical illness or medical treatment that would preclude or inhibit study participation.
- Neurological disorder associated with brain damage.
- History of seizures or head trauma with loss of consciousness > 5 minutes.
- Family history of epilepsy or personal epilepsy/seizures
- Ferromagnetic implants or ferrmagnetic objects within body (e.g., pacemaker).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMS A
Active continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)
|
TMS will be administered using a Cool B-65 coil to a personalized right dlPFC region.
|
|
Sham Comparator: TMS B
Sham continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)
|
TMS will be administered using a Cool B-65 coil to a personalized right dlPFC region.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social motivation
Time Frame: Immediately post-intervention
|
Motivational responses to facial expressions as measured by the Social Approach Avoidance Paradigm (SAAP; Evans, Esterman, & Britton, 2022).
In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions.
|
Immediately post-intervention
|
|
Neural circuit function
Time Frame: Immediately post-intervention
|
Brain connectivity during motivational responses to facial expression during the Social Approach-Avoidance Paradigm (SAAP; Evans, Esterman, & Britton, 2022) and during resting state conditions.
In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions.
During resting state conditions, participants simply lie still with their eyes open without completing any type of task.
|
Immediately post-intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1K23MH135222 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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