Modulating Anxious Coping

NCT04824105 | Recruiting

• 2 other identifiers: 001068431K23MH123931-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to find out if a device that temporarily alters brain activity (repetitive transcranial magnetic stimulation, rTMS) might be used to change how people with anxiety or related concerns cope with feared or anxiety-producing situations. The study is recruiting people who recently started treatment for anxiety or a related concern. The study involves 3 visits to the Medical University of South Carolina. At the first visit, participants do interviews and surveys asking about anxiety and related concerns, and they also do tasks where they see and react to emotional pictures while their brain activation is measured. At the next two visits, participants receive rTMS, which works by rapidly turning a focused magnetic field on and off repeatedly over the head in a way that passes directly through the hair, scalp, and skull and onto the brain and can temporarily increase brain activity under the magnetic field. After rTMS, participants do two tasks where they see and react to emotional situations while wearing sensors on their hand, arms, face, and head. Each visit in this study is expected to last between 2 - 4 hours. This is not a treatment study, but the study is being conducted with the hope that it will help improve treatment in the future.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Change in Fear-Potentiated Startle Reflex

  Fear-potentiated startle is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Fear-potentiated startle measures motivational activation during the preparation period.

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

• Change in Speed to Initiate Avoidance Behavior

  Reaction time to initiate flight is measured in an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Reaction time measures behavioral tendency to approach or avoid.

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

Secondary Outcomes (7)

• Change in Escape/ Avoidance Electroencephalography

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

• Change in Approach/ Avoidance Conflict Electroencephalography

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

• Change in Task-Related Heart Rate Changes

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

• Change in Task-Related Skin Conductance Responding

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

• Change in Task-Related Perceived Control

  Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)

Other Outcomes (1)

• Task-Related Brain Activation

  During Session (Approx. 45 minutes)

Study Arms (1)

Neurostimulation Group

EXPERIMENTAL

On one study day, participants will complete experimental tasks during functional magnetic resonance imaging. On two other study days, participants will complete tasks before and after receiving repetitive transcranial magnetic stimulation (rTMS). All participants will receive rTMS to ventromedial prefrontal cortex on one study day, and to pre-supplementary motor area on another study day. Two stimulation procedures will be used, one for ventromedial prefrontal cortex and one for pre-supplementary motor area. For both targets, 3 sessions of 600 pulses at 110% of resting motor threshold will be presented over 30 minutes. For ventromedial cortex, a session will involve intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds. For pre-supplementary motor area, a session will involve continuous theta burst presented in 3-pulse bursts with 15 pulses/ sec.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

A repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System will be used to deliver intermittent theta burst to ventromedial prefrontal cortex, and continuous theta burst to pre-supplementary motor area.

Neurostimulation Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• y.o.
• Meets criteria for an anxiety disorder (Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Specific Phobia), posttraumatic stress disorder, obsessive- compulsive disorder, or current adjustment disorder with anxiety
• Is currently seeking mental health treatment
• Is able to read consent document and provide informed consent.
• English is a first or primary fluent language.

You may not qualify if:

• Current alcohol or substance use disorder of more than mild severity (as defined by DSM-5 and determined using standardized self-report instruments)
• Lifetime diagnosis of psychotic disorder or bipolar mania
• Presence of neurological disorder that contraindicates TMS or neurophysiological recording: Seizure disorder Lifetime history of traumatic brain injury with loss of consciousness Neurodegenerative disorder (e.g., Alzheimer's Disease, Parkinson's Disease, Frontotemporal Dementia)
• Presence of other medical disorder that would make it too uncomfortable to sit or lie still for long recording periods
• Presence of standard contraindications for MRI or rTMS Metal in the body Currently pregnant Claustrophobia Significant sensitivity to noise Medical conditions or treatments that lower seizure threshold History of severe brain injury History of seizures/ epilepsy
• Currently taking anticholinergic mediation, neuroleptic medication, or sedative/ hypnotic medication Note: SSRI, cholinesterase inhibitors or NMDA receptor antagonists are allowed if patient has been on a stable regimen of four weeks prior to enrollment
• Currently taking chronic opiate medications or substances
• Currently taking naltrexone

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Christopher T Sege, PhD

CONTACT

8437928465; sege@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: June 26, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Immediately following publication of primary project manuscript, or by 6 months after study completion, whichever is earlier.
• Access Criteria: De-identified data will be made available through upload to the NITRIC Data Repository. As such, de-identified data will be publically available.

Locations

US (1)