Modulating Anxious Coping

Anxiety Disorders Clinical Trial

Official title:

Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04824105
• Other study ID #: 00106843
• Secondary ID: 1K23MH123931-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: Christopher T Sege, PhD
• Phone: 8437928465
• Email: sege[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 - 65 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Task-Related Brain Activation	Blood flow in the brain will be measured during completion of two experimental tasks using functional magnetic resonance imaging (fMRI). Blood flow in the brain can be used to measure what brain areas are being activated during the performance of a task.	During Session (Approx. 45 minutes)
Primary	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)
Primary	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	Change in Escape/ Avoidance Electroencephalography	Electroencephalography (EEG) is measured during an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. An event-related potential, the stimulus-preceding negativity, will be derived from the EEG to index action preparation processing.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in Approach/ Avoidance Conflict Electroencephalography	Electroencephalography (EEG) is measured during an experimental task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. A frequency signature, power in the theta frequency band, will be derived from the EEG to index cognitive control processes.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in Task-Related Heart Rate Changes	Heart rate is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Heart rate slowing measures task-related engagement of attention, while heart rate increase indicates defensive activation.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in Task-Related Skin Conductance Responding	Skin conductance is measured during experimental tasks in which: 1) participants prepare to avoid, escape, or simply be exposed to aversive pictures; 2) participants can win money but also must evade a slow, moderate, or fast virtual predator. Skin conductance increases indicate task-related sympathetic arousal.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in Task-Related Perceived Control	Perceived control over aversive stimuli is queried after an experimental task in which participants prepare to avoid, escape, or simply be exposed to aversive pictures. Perceived control for each condition is queried using self-report Likert-type scales for each condition.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in Difficulty of Avoiding Task-Based Aversive Exposure	Difficulty of avoiding exposure to aversive stimulation is queried after each trial during a task in which participants can win money but also must evade a slow, moderate, or fast virtual predator. Avoidance difficulty is queried using a Likert-type scale delivered after each trial. The scale ranges from 1 to 5, with higher scores indicating greater perceived difficulty of avoiding capture by the virtual predator.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary	Change in State Anxiety During Session	State-level anxiety is measured throughout the experimental session using the State-Trait Anxiety Inventory - State Form. The State-Trait Anxiety Inventory - State Form uses 20 items querying anxiety symptom experience in the present moment to measure how anxiety fluctuates across the experimental session. The scale ranges from 20 to 80, with higher scores indicating higher state anxiety.	Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)