Modulating Anxious Coping
ConditionAnxiety Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMedical University of South Carolina
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceA 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Neurostimulation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)2
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)Secondary outcomes
1
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)2
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)3
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)4
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.
Time frame
Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)Other outcomes
1
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.
Time frame
During Session (Approx. 45 minutes)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov