Anxiety DisordersNCT04824105
Modulating Anxious Coping
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Anxiety Disorders, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Christopher T Sege, 978-764-1480, sege@musc.edu
About this study
Official title: Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum
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
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Secondary outcomes (7)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Measured: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start26 Jun 2021
- Primary completion31 Aug 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824105
- Sponsor's protocol ID
- 00106843
- Other IDs
- 1K23MH123931-01A1
- Status last verified
- Nov 2026
- First submitted
- 24 Mar 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Objective data will be archived in raw format on the NITRIC Data Repository. Sufficient description of tasks and event markers will be included to allow reprocessing and replication by trained researchers. Original, albeit cleaned and de-identified, self-report data will also be included. Cleaning will entail the most basic review of each variable to assure correct coding, and, in justified cases, invert variable scores to make variables easier to interpret. Inversions will always be noted. DATA FORMAT: Objective data will be delivered to NITRIC in NIFTII format for fMRI data and tab-delimited text files for EEG and physiology data. Self-report data will be delivered in SPSS .sav format. No identifying information will be included. VARIABLE CREATION: All variable computation, weighting, and imputation syntax will be in SPSS format and delivered in .txt file. A variable definition list / codebook will also be delivered.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum
- ClinicalTrials.gov ID
- NCT04824105
- Acronym / sponsor ID
- 00106843
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulation Group | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Neurostimulation Group |
Primary outcome
Change in Fear-Potentiated Startle Reflex
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
Change in Speed to Initiate Avoidance Behavior
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
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.
7 secondary outcomes
Change in Escape/ Avoidance Electroencephalography
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Approach/ Avoidance Conflict Electroencephalography
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Task-Related Heart Rate Changes
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Task-Related Skin Conductance Responding
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Task-Related Perceived Control
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in Difficulty of Avoiding Task-Based Aversive Exposure
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Change in State Anxiety During Session
Time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Objective data will be archived in raw format on the NITRIC Data Repository. Sufficient description of tasks and event markers will be included to allow reprocessing and replication by trained researchers. Original, albeit cleaned and de-identified, self-report data will also be included. Cleaning will entail the most basic review of each variable to assure correct coding, and, in justified cases, invert variable scores to make variables easier to interpret. Inversions will always be noted. DATA FORMAT: Objective data will be delivered to NITRIC in NIFTII format for fMRI data and tab-delimited text files for EEG and physiology data. Self-report data will be delivered in SPSS .sav format. No identifying information will be included. VARIABLE CREATION: All variable computation, weighting, and imputation syntax will be in SPSS format and delivered in .txt file. A variable definition list / codebook will also be delivered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Anxiety Disorders, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher T Sege, PhD (8437928465, sege@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fear-Potentiated Startle Reflex (time frame: Immediately Pre-Stimulation and Immediately Post-Stimulation (Approx. 30 minutes between assessments)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.