Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:09 AM
Study NCT ID:
NCT07463703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-11
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003130', 'term': 'Combat Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Treatment initiation through 3 months post-treatment (approx. 95 days total)', 'description': 'Treatment-emergent adverse events (TEAEs) will be assessed from the first TMS session through 3 months post-treatment. TEAEs include any adverse event emerging or worsening after treatment onset.\n\nMonitored events include:\n\nLocal effects: headache, scalp discomfort, tinnitus Neurological: seizure, syncope, facial twitching Psychiatric: PTSD exacerbation, suicidality (C-SSRS), mood changes Systemic: fatigue, dizziness\n\nSeverity will be graded per CTCAE v5.0 (Grades 1-5) and causality rated by the principal investigator. Assessments occur at each treatment session, end of treatment, and at 1- and 3-month follow-ups.\n\nSAEs (including seizure or emergent suicidality) will be reported to the IRB within 24 hours. The DSMB will review safety data at pre-specified interim analyses.'}], 'primaryOutcomes': [{'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': 'Baseline, post-treatment 5 days, 1 month, 3 months', 'description': 'A change in PTSD severity will be measured via administration of the PDSD Checklist for DSM-5 (PCL-5). This is a 20-question Likert scale, with scores ranging from 0 to 80. Higher scores indicate stronger PTSD symptoms.'}], 'secondaryOutcomes': [{'measure': 'Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)', 'timeFrame': 'Baseline, post-treatment 5 days, 3 months', 'description': 'The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is the gold-standard PTSD assessment. It is a 30-item structured interview that can assess PTSD symptoms over the past week, as well as make current or lifetime diagnoses of PTSD. We will measure change in CAPS-5 score between baseline and 5 days post-treatment.'}, {'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Baseline, post-treatment 5 days, 1 month, 3 months', 'description': 'The Beck Depression Inventory-II (BDI-II) is a 21-question self-report survey measuring the severity of depression in adolescents and adults.'}, {'measure': 'Patient Global Impression of Change (PGI-C)', 'timeFrame': 'Post-treatment 5 days, 3 months', 'description': "7-point self-reported instrument that measures a patient's belief about the efficacy of a treatment"}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, treatment days 1, 2, 3, 4, and 5, post-treatment 5 days, 1 month, 3 months', 'description': 'The Columbia Suicide Severity Rating Scale (C-SSRS) is a standardized clinical tool used to identify and assess the risk of suicide. It isn\'t scored with a single total number but by interpreting "Yes/No" answers to identify risk levels (low, moderate, high) and specific suicidal ideation/behavior categories, with positive answers to later questions (like intent, specific plans, or preparatory acts) indicating higher, immediate risk requiring urgent intervention.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Post Traumatic Stress Disorder'], 'conditions': ['PTSD - Post Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness.\n\nThe investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses.\n\nThe study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes.\n\nThis study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.', 'detailedDescription': 'This pilot study evaluates the feasibility, safety, and preliminary efficacy of functional magnetic resonance imaging (fMRI)-guided accelerated continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (rDLPFC) in adults with post-traumatic stress disorder (PTSD). PTSD is characterized by dysregulation in the fear circuitry, including amygdala hyperreactivity and impaired prefrontal regulation, leading to persistent symptoms despite standard treatments like trauma-focused psychotherapy or selective serotonin reuptake inhibitors, which achieve adequate response in only about 50% of patients.\n\nThe intervention leverages resting-state fMRI to identify individualized rDLPFC targets based on maximal positive functional connectivity to the right amygdala, addressing inter-individual variability in circuit topography (average 4.5 cm variation per recent literature). Imaging is acquired on a 1.5T scanner with T1-weighted structural (MPRAGE: TR=1645 ms, TE=3.8 ms, voxel=0.8 mm isotropic) and resting-state functional sequences (EPI: TR=2000 ms, TE=40 ms, voxel=3.75×3.75×4 mm, 900 volumes). Data processing via FSL includes motion correction, spatial smoothing (5 mm FWHM), bandpass filtering (0.01-0.1 Hz), and nuisance regression. The peak correlation voxel in the rDLPFC (Brodmann areas 8,9,10,46) serves as the target; fallback to MNI \\[40,28,44\\] if data quality fails.\n\nTreatment employs an accelerated cTBS protocol over 5 consecutive days (50 sessions total: 10/day, 1,800 pulses/session, 90,000 pulses overall) using ANT Visor 2 neuronavigation for precise coil positioning. Each session delivers bursts of 3 pulses at 50 Hz, repeated at 5 Hz for 40 seconds (600 pulses/train), with 3 trains and 30-second inter-train intervals, at 65-80% resting motor threshold (determined via EMG over the first dorsal interosseous). Inter-session intervals are 50 minutes, with continuous monitoring for adverse events.\n\nThe single-arm, open-label design includes a screening/baseline phase (informed consent, medical history, safety screenings), baseline fMRI for targeting, treatment phase with daily safety checks, post-treatment assessments (within 48-72 hours), and follow-ups at 1 and 3 months. Total participant commitment is \\~3.5 months. Pre- and post-treatment fMRI explores mechanistic changes in rDLPFC-amygdala connectivity (seed-to-seed Pearson correlation, Fisher z-transformed) and target shifts (Euclidean distance, component decomposition), correlating with clinical improvements.\n\nThis approach combines precision neuromodulation with accelerated delivery to reduce treatment burden (5 days vs. 4-6 weeks standard), building on meta-analyses showing moderate-to-large TMS effects in PTSD (SMD=1.02) and FDA-cleared neuroimaging-guided protocols like SAINT. The study aims to generate proof-of-concept data for larger randomized trials, focusing on circuit-specific modulation to enhance fear extinction and prefrontal control. Safety is prioritized with strict contraindication screening, real-time monitoring, and an independent safety monitor reviewing serious adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\nParticipants must meet ALL of the following criteria:\n\n1. Age 18-65 years (inclusive)\n2. DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)\n3. PCL-5 total score ≥33 (indicating at least moderate symptom severity)\n4. PTSD symptom duration ≥3 months\n5. If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation\n6. Able to provide written informed consent\n7. English-speaking (required for validated assessment measures)\n8. Able to attend daily treatment sessions for 5 consecutive weekdays\n9. Eligible for 1.5T MRI scanning (no contraindications)\n\nExclusion Criteria\n\nParticipants meeting ANY of the following criteria will be excluded:\n\nTMS Contraindications:\n\n1. Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head or within 30 cm of the TMS coil (excluding the mouth), including:\n\n * Cochlear implants\n * Deep brain stimulators\n * Vagus nerve stimulators\n * Aneurysm clips or coils\n * Stents in the neck or brain\n * Electrodes\n * Any implanted electronic devices\n2. History of seizure disorder (excluding single childhood febrile seizure)\n3. First-degree family member with epilepsy\n4. History of significant head trauma with loss of consciousness \\>10 minutes\n5. History of stroke, brain tumor, or other neurological disorder\n6. Neurosurgical procedures involving brain tissue\n\nMRI Contraindications:\n\n1. Implanted medical devices incompatible with MRI\n2. Claustrophobia preventing MRI scan completion\n3. Body size preventing MRI scanner entry\n\nPsychiatric Exclusions:\n\n1. Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)\n2. Lifetime history of bipolar I disorder\n3. Current (within past month) moderate or severe substance use disorder per DSM-5 criteria\n4. Current active suicidal ideation with intent or plan (Columbia Suicide Severity Rating Scale score ≥4)\n5. Psychiatric hospitalization within past 3 months\n\n Medical Exclusions:\n6. Unstable medical condition that, in the investigator's judgment, would interfere with study participation or pose safety risk\n7. Pregnancy or breastfeeding (females of childbearing potential must have negative urine pregnancy test at screening)\n8. Prior TMS treatment within past 3 months\n9. Current participation in another interventional research study\n10. Initiation of psychotherapy specifically for PTSD within past 3 months (stable ongoing therapy is permitted)"}, 'identificationModule': {'nctId': 'NCT07463703', 'briefTitle': 'Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cognitive FX'}, 'officialTitle': 'Feasibility and Preliminary Efficacy of Functional MRI-Guided Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder: A Pilot Study', 'orgStudyIdInfo': {'id': 'COMPASS-PTSD-1.0.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active accelerated TMS stimulation', 'description': 'This is a single-arm, open-label pilot study. All enrolled participants will receive active fMRI-guided accelerated cTBS treatment to the right dorsolateral prefrontal cortex (rDLPFC). The study includes a screening/baseline phase, a 5-day treatment phase, and a 3-month follow-up phase.', 'interventionNames': ['Device: Accelerated functional-connectivity guided transcranial magnetic stimulation']}], 'interventions': [{'name': 'Accelerated functional-connectivity guided transcranial magnetic stimulation', 'type': 'DEVICE', 'description': "Resting state functional connectivity scanning will be used to identify the peak positive correlate of the right amygdala in the right dorsolateral prefrontal cortex. This target will be stimulated during 50 sessions over 5 days, 10 sessions per day. Each TMS session will consist of 3 trains of 600-pulse continuous theta burst stimulation (cTBS). Each train consists of 3-pulse 50-Hz bursts at 5-Hz for 40-second trains, with trains every 70 seconds. This stimulation will be applied at 80% of the patient's resting motor threshold. Target site will be identified using ANT Neuro Visor2 neuronavigation system.", 'armGroupLabels': ['Active accelerated TMS stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Cognitive FX TMS Clinic', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}], 'centralContacts': [{'name': 'Lynn Gaufin, MD', 'role': 'CONTACT', 'email': 'tms.info@cognitivefxusa.com', 'phone': '385-446-4158'}, {'name': 'Mark Allen, PhD', 'role': 'CONTACT', 'email': 'mark@cognitivefxusa.com'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All individual participant data underlying the text, tables, figures, and appendices reported in this trial, after deidentification.', 'accessCriteria': 'Researchers who provide a methodologically sound proposal can access the data upon request via email to tms.info@cognitivefxusa.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cognitive FX', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}