Clinical trial NCT04824105: Modulating Anxious Coping
Official title: Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-04-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Fear-Potentiated Startle Reflex
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Speed to Initiate Avoidance Behavior
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary outcomes:
measure: Change in Escape/ Avoidance Electroencephalography
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Approach/ Avoidance Conflict Electroencephalography
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Task-Related Heart Rate Changes
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Task-Related Skin Conductance Responding
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Task-Related Perceived Control
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in Difficulty of Avoiding Task-Based Aversive Exposure
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
measure: Change in State Anxiety During Session
timeFrame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Other outcomes:
measure: Task-Related Brain Activation
timeFrame: During Session (Approx. 45 minutes)
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: