Using TMS to Understand Neural Processes of Social Motivation

Major Depressive Disorder Clinical Trial

Official title:

Personalized Neuromodulation Targeting Dysregulated Motivational Responses Underlying Social Avoidance Behavior

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274112
• Other study ID #: 1K23MH135222
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2029

Study information

• Verified date: February 2024
• Source: Auburn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/Apelika area 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2029
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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 screening visit).

Exclusion Criteria:

• Unstable medication regimen (i.e., changes in 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 or prior neurosurgical procedure.
• History of seizures or head trauma.
• Metal implants or objects within body (e.g., pacemaker).

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Phobia, Social
• Social Anxiety Disorder

Intervention

Device:
• TMS
TMS will be administered in either an active format that induces neuromodulatory effects or a sham comparison format that does not induce neuromodulatory effects.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Auburn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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