Using TMS to Understand Neural Processes of Social Motivation

NCT06274112 | Recruiting DMC FDA Device

• 1 other identifier: 1K23MH135222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Avoidant Behavior; Major Depressive Disorder; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

• Social motivation

  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

  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

Study Arms (2)

TMS A

EXPERIMENTAL

Active continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)

Device: TMS

TMS B

SHAM COMPARATOR

Sham continuous thetaburst stimulation administered over right dorsolateral prefrontal cortex for 40 seconds (600 pulses total)

Device: TMS

Interventions

TMS DEVICE

TMS will be administered using a Cool B-65 coil to a personalized right dlPFC region.

TMS A; TMS B

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Phobia, Social

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Phobic Disorders; Anxiety Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants will receive each dose of TMS in a counterbalanced order (AB or BA)

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: September 30, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

US (1)