PTSDEarly Phase 1NCT07785908
Individualized (fMRI-guided) TMS Intervention for Post-Traumatic Stress Disorder (PTSD)
A Early Phase 1 study testing Active Transcranial Magnetic Stimulation (TMS) in people with PTSD and Post Traumatic Stress Disorder (PTSD), run by University of Pennsylvania.
Trial summary
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the amygdala in adults with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Post Traumatic Stress Disorder (PTSD)
- What is being tested?
- Active Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to Aug 2028
- Phase
- Early Phase 1
- 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
- In order to participate in this study, potential participants must meet all of the following eligibility criteria:
- 18-65 years old
- Current diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria, as assessed by the Clinician-Administered PTSD Scale-5.
- Patient Health Questionnaire (PHQ-9) score = or > than 10
- Comprehension of instructions in the English language.
- Capacity to provide informed consent and follow study procedures.
- Availability for the duration of the study.
Who cannot join
- Any individual who meets any of the following criteria at the time of enrollment will be excluded from participation:
- Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
- History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
- Current substance use disorder.
- History of a psychotic or bipolar disorder, including manic or hypomanic episodes.
- Prior failed response to full rTMS or Electroconvulsive Therapy (ECT)/Magnetic Seizure Therapy (MST) trial. Any successful prior treatments are acceptable and support a prognosis that a new rTMS treatment would be worth attempting.
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- Inability to complete an MRI scan (e.g., claustrophobia, inability to remain still for extended periods).
- Inability to tolerate TMS administration
- Significant handicaps that would interfere with testing procedures
- Acute systemic infection, high fever
- Acute sleep deprivation or medication/substance intoxication or withdrawal (TMS seizure risk)
- Current use of cyclosporine, tacrolimus, or others that can cause leukoencephalopathy.
- Pregnancy
- Dialysis
- Suicide attempt in past 6 months (safety precaution); similarly, if ideation is particularly pronounced, Drs. Oathes and Sheline will decide with the patient whether the benefit of participating in a sham controlled (all patients given the option to receive active treatment eventually) study outweighs the risks. If the patient has a mental health provider and acquiesces, consultation with the provider will also be instrumental in this decision.
- Current use of Bupropion (Wellbutrin) above 300 mg, benzodiazepines, lithium, monoamine oxidase inhibitors (MAOIs), and/or high doses of stimulant medication is exclusionary. Note: Exclusionary dosages or medications may be reduced or discontinued under the supervision of a medical provider.
- Transportation limits or physical limits to attending daily M-F treatment sessions.
- Per study physician discretion medications likely to interfere with blood flow or otherwise compromise functional imaging measures.
- Any other factor that in the investigators' judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from procedure site; unlikely to be able to schedule daily treatment sessions, etc.)
- DURING STUDY REQUIREMENTS
- During this study, participants will be asked to:
- Refrain from substance use (including marijuana and illicit drugs) for the duration of the study (self-attestation alone)
- Abstain from alcohol for 24 hours before study visits (self-attestation alone)
- Maintain a consistent level of caffeine consumption throughout the study period and avoid any significant increases (self-attestation).
- Not initiate, discontinue, or adjust any psychiatric medications or therapy treatments during the study period.
- Inform the study team of any new medical treatments or prescribed medications (e.g., antibiotics) to allow for safety review and determination of continued eligibility for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Engaging the Amygdala With Brain Stimulation for PTSD
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the amygdala in adults with posttraumatic stress disorder (PTSD). The main questions it aims to answer are:
- Can MRI-guided TMS engage the amygdala by stimulating an individualized brain target connected to the amygdala?
- Does stimulation of this individualized target engage the amygdala differently than stimulation of control sites?
- Does a 6-week course of active TMS, compared with sham TMS, change amygdala responses and physiological responses to fear?
Read more
Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and fear-related responses.
Participants will:
- Receive active or sham TMS every weekday for 6 weeks
- Undergo MRI scans with TMS before and after the 6-week intervention to measure brain responses to stimulation
- Participate in fear learning and memory tasks while physiological responses are measured
- Undergo additional MRI scans, clinical assessments, questionnaires, and cognitive testing
- Complete remote follow-up assessments at 1, 6, and 12 months after the intervention
Read the detailed description
This double-blind, randomized, sham-controlled clinical trial will investigate engagement and modulation of amygdala-related brain circuitry using individualized resting-state functional magnetic resonance imaging (fMRI)-guided transcranial magnetic stimulation (TMS) in adults with posttraumatic stress disorder (PTSD).
Following screening, participants will undergo a baseline MRI session that includes structural, diffusion, and resting-state imaging. Resting-state functional connectivity will be used to identify an individualized cortical stimulation target within the ventrolateral prefrontal cortex (vlPFC) that is positively connected with the basolateral amygdala.
Before the 6-week intervention, participants will undergo a TMS/fMRI session to evaluate whether stimulation of the individualized target engages the amygdala. Single-pulse TMS will be delivered to three sites: the individualized amygdala-connected target, an individualized cortical control target with minimal functional connectivity to the amygdala, and a vertex control site. Amygdala blood oxygen level-dependent (BOLD) responses during TMS will be measured to assess target engagement and determine whether amygdala responses differ across stimulation sites.
Participants will then be randomized in a 1:1 ratio to receive active or sham intermittent theta burst stimulation (iTBS) delivered to the individualized amygdala-connected target every weekday for 6 weeks (30 sessions). Sham procedures will be designed to resemble active stimulation without delivering the intended magnetic stimulation to the targeted brain circuit.
Psychophysiological assessments will be conducted before, during, and after the intervention to evaluate fear learning, extinction, and extinction retention. During these tasks, physiological responses to fear-related stimuli will be measured. Following the 6-week intervention, participants will undergo a second TMS/fMRI session using the same stimulation targets and procedures as the pre-intervention session. Changes in amygdala responses from pre- to post-intervention will be compared between the active and sham groups to evaluate modulation of the targeted brain circuit.
Clinical assessments, questionnaires, and cognitive testing will also be conducted throughout the study. Participants will complete remote follow-up assessments at 1, 6, and 12 months after their last TMS intervention session. After the 1-month follow-up, participants assigned to sham will be unblinded and may be offered an optional open-label active TMS intervention if they continue to have clinically significant PTSD symptoms and meet study eligibility criteria.
- Conditions
- PTSD, Post Traumatic Stress Disorder (PTSD)
- Being tested
- Active Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (TMS)
- Keywords
- Transcranial Magnetic Stimulation, TMS, Brain Stimulation, Non-invasive Brain Stimulation, TMS for PTSD, PTSD, TMS for depression, MRI-guided TMS, fMRI, treatment for PTSD, TMS treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Magnetic Stimulation (TMS)Device
The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized amygdala-connected cortical target using MRI-guided neuronavigation.
Sham Transcranial Magnetic Stimulation (TMS)Device
The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Experimental | Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized ventrolateral prefrontal cortex (vlPFC) target selected based on positive resting-state functional connectivity with the basolateral amygdala. Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted vlPFC-amygdala circuit. Receives: Device: Active Transcranial Magnetic Stimulation (TMS) |
| Sham iTBS | Placebo comparator | Participants will receive sham iTBS at the same individualized amygdala-connected vlPFC target every weekday for 6 weeks (30 sessions). Receives: Device: Sham Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average amygdala blood-oxygen-level-dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs. TMS Off) to the individualized amygdala-connected target.
This primary endpoint compares amygdala BOLD signal during TMS On and TMS Off conditions, averaging across participants, providing a direct assessment of average amygdala engagement during fMRI-guided TMS. The change in BOLD signal observed in this comparison is defined as the amygdala-evoked response. This endpoint addresses the lack of mechanistic knowledge regarding amygdala engagement in PTSD when using individualized resting-state fMRI connectivity to guide TMS targeting.
Measured: Single visit (~2 hours)
Secondary outcomes (2)
Difference in average amygdala-evoked response from TMS stimulation to fMRI-guided sites versus TMS stimulation of control sites.
This secondary endpoint provides further mechanistic knowledge regarding amygdala engagement in PTSD when using individualized resting-state fMRI connectivity to guide TMS targeting by comparing the effectiveness of the fMRI-guided targeting to stimulation of a control site that is not expected to evoke a response in the amygdala.
Measured: Single visit (~2 hours)
(1) Difference in amygdala-evoked response from pre-treatment to post-treatment between active rTMS and sham; (2) difference in psychophysiological measures of fear extinction retention between active repetitive TMS (rTMS) and sham.
This secondary endpoint evaluates whether repeated stimulation of an individualized amygdala-connected cortical target is associated with measurable changes in amygdala responsivity following treatment relative to a sham rTMS condition. Differential changes in the amygdala-evoked response between active and sham rTMS would provide evidence that the targeted cortico-amygdala circuit can be modulated with rTMS. Fear extinction retention measures will serve as a complementary physiological index of treatment-related changes in fear-processing circuits relative to sham.
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start12 Oct 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to receive active or sham iTBS every weekday for 6 weeks (30 sessions). In both groups, stimulation will be delivered to an individualized ventrolateral prefrontal cortex (vlPFC) target selected based on positive resting-state functional connectivity with the basolateral amygdala. The active group will receive iTBS intended to stimulate the targeted vlPFC-amygdala circuit, while the sham group will undergo procedures of the same duration and appearance without the intended magnetic stimulation of the targeted circuit.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desmond Oathes, University of Pennsylvania
- Investigators
- Desmond Oathes, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785908
- Sponsor's protocol ID
- 26-7454
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging the Amygdala With Brain Stimulation for PTSD
- ClinicalTrials.gov ID
- NCT07785908
- Acronym / sponsor ID
- 26-7454
- Conditions
- PTSD, Post Traumatic Stress Disorder (PTSD)
- Keywords
- Transcranial Magnetic Stimulation, TMS, Brain Stimulation, Non-invasive Brain Stimulation, TMS for PTSD, PTSD, TMS for depression, MRI-guided TMS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the amygdala in adults with posttraumatic stress disorder (PTSD). The main questions it aims to answer are:
- Can MRI-guided TMS engage the amygdala by stimulating an individualized brain target connected to the amygdala?
- Does stimulation of this individualized target engage the amygdala differently than stimulation of control sites?
- Does a 6-week course of active TMS, compared with sham TMS, change amygdala responses and physiological responses to fear?
Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and fear-related responses.
Participants will:
- Receive active or sham TMS every weekday for 6 weeks
- Undergo MRI scans with TMS before and after the 6-week intervention to measure brain responses to stimulation
- Participate in fear learning and memory tasks while physiological responses are measured
- Undergo additional MRI scans, clinical assessments, questionnaires, and cognitive testing
- Complete remote follow-up assessments at 1, 6, and 12 months after the intervention
Detailed description
This double-blind, randomized, sham-controlled clinical trial will investigate engagement and modulation of amygdala-related brain circuitry using individualized resting-state functional magnetic resonance imaging (fMRI)-guided transcranial magnetic stimulation (TMS) in adults with posttraumatic stress disorder (PTSD).
Following screening, participants will undergo a baseline MRI session that includes structural, diffusion, and resting-state imaging. Resting-state functional connectivity will be used to identify an individualized cortical stimulation target within the ventrolateral prefrontal cortex (vlPFC) that is positively connected with the basolateral amygdala.
Before the 6-week intervention, participants will undergo a TMS/fMRI session to evaluate whether stimulation of the individualized target engages the amygdala. Single-pulse TMS will be delivered to three sites: the individualized amygdala-connected target, an individualized cortical control target with minimal functional connectivity to the amygdala, and a vertex control site. Amygdala blood oxygen level-dependent (BOLD) responses during TMS will be measured to assess target engagement and determine whether amygdala responses differ across stimulation sites.
Participants will then be randomized in a 1:1 ratio to receive active or sham intermittent theta burst stimulation (iTBS) delivered to the individualized amygdala-connected target every weekday for 6 weeks (30 sessions). Sham procedures will be designed to resemble active stimulation without delivering the intended magnetic stimulation to the targeted brain circuit.
Psychophysiological assessments will be conducted before, during, and after the intervention to evaluate fear learning, extinction, and extinction retention. During these tasks, physiological responses to fear-related stimuli will be measured. Following the 6-week intervention, participants will undergo a second TMS/fMRI session using the same stimulation targets and procedures as the pre-intervention session. Changes in amygdala responses from pre- to post-intervention will be compared between the active and sham groups to evaluate modulation of the targeted brain circuit.
Clinical assessments, questionnaires, and cognitive testing will also be conducted throughout the study. Participants will complete remote follow-up assessments at 1, 6, and 12 months after their last TMS intervention session. After the 1-month follow-up, participants assigned to sham will be unblinded and may be offered an optional open-label active TMS intervention if they continue to have clinically significant PTSD symptoms and meet study eligibility criteria.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to receive active or sham iTBS every weekday for 6 weeks (30 sessions). In both groups, stimulation will be delivered to an individualized ventrolateral prefrontal cortex (vlPFC) target selected based on positive resting-state functional connectivity with the basolateral amygdala. The active group will receive iTBS intended to stimulate the targeted vlPFC-amygdala circuit, while the sham group will undergo procedures of the same duration and appearance without the intended magnetic stimulation of the targeted circuit.
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Experimental | Device: Active Transcranial Magnetic Stimulation (TMS)Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized ventrolateral prefrontal cortex (vlPFC) target selected based on positive resting-state functional connectivity with the basolateral amygdala. Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted vlPFC-amygdala circuit. |
| Sham iTBS | Placebo comparator | Device: Sham Transcranial Magnetic Stimulation (TMS)Participants will receive sham iTBS at the same individualized amygdala-connected vlPFC target every weekday for 6 weeks (30 sessions). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, potential participants must meet all of the following eligibility criteria:
- 18-65 years old
- Current diagnosis of PTSD based on Diagnostic and Statistical Manual of Mental Disorders-5 criteria, as assessed by the Clinician-Administered PTSD Scale-5.
- Patient Health Questionnaire (PHQ-9) score = or > than 10
- Comprehension of instructions in the English language.
Key exclusion criteria (26 listed)
- Any individual who meets any of the following criteria at the time of enrollment will be excluded from participation:
- Implanted medical devices, metallic implants, or drug infusion pumps that are not MRI-safe (e.g., aneurysm clips, defibrillators, or cochlear implants)
- History of significant medical events (e.g., stroke, seizures, brain scarring) or neurological/neurodevelopmental conditions (e.g., epilepsy) that are contraindications for TMS and MRI or may adversely affect brain function and data interpretation.
- Current substance use disorder.
- History of a psychotic or bipolar disorder, including manic or hypomanic episodes.
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 |
|---|---|---|
| Active Transcranial Magnetic Stimulation (TMS)The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized amygdala-connected cortical target using MRI-guided neuronavigation. | Device | Active iTBS |
| Sham Transcranial Magnetic Stimulation (TMS)The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region. | Device | Sham iTBS |
Primary outcome
Average amygdala blood-oxygen-level-dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs. TMS Off) to the individualized amygdala-connected target.
Time frame: Single visit (~2 hours)
This primary endpoint compares amygdala BOLD signal during TMS On and TMS Off conditions, averaging across participants, providing a direct assessment of average amygdala engagement during fMRI-guided TMS. The change in BOLD signal observed in this comparison is defined as the amygdala-evoked response. This endpoint addresses the lack of mechanistic knowledge regarding amygdala engagement in PTSD when using individualized resting-state fMRI connectivity to guide TMS targeting.
2 secondary outcomes
Difference in average amygdala-evoked response from TMS stimulation to fMRI-guided sites versus TMS stimulation of control sites.
Time frame: Single visit (~2 hours)
(1) Difference in amygdala-evoked response from pre-treatment to post-treatment between active rTMS and sham; (2) difference in psychophysiological measures of fear extinction retention between active repetitive TMS (rTMS) and sham.
Time frame: Up to 7 weeks
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Desmond Oathes, PhD principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Active Transcranial Magnetic Stimulation (TMS) in people with PTSD and Post Traumatic Stress Disorder (PTSD), run by University of Pennsylvania.
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 7 inclusion and 26 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: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Almaris Figueroa Gonzalez (2157466751, almaris.figueroa-gonzalez@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average amygdala blood-oxygen-level-dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs. TMS Off) to the individualized amygdala-connected target. (time frame: Single visit (~2 hours)). 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 31 Aug 2026.