Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCognitive FX
About this trial
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.
The 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.
The 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.
This 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-65 years (inclusive)
DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
PCL-5 total score ≥33 (indicating at least moderate symptom severity)
PTSD symptom duration ≥3 months
Disqualifiers
Cochlear implants
Deep brain stimulators
Vagus nerve stimulators
Aneurysm clips or coils
Trial design
Design model
Single group
Treatments tested in this trial
Accelerated functional-connectivity guided transcranial magnetic stimulation
DeviceResting 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Active accelerated TMS stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PTSD Checklist for DSM-5 (PCL-5)
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.
Time frame
Baseline, post-treatment 5 days, 1 month, 3 monthsSecondary outcomes
1
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
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.
Time frame
Baseline, post-treatment 5 days, 3 months2
Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a 21-question self-report survey measuring the severity of depression in adolescents and adults.
Time frame
Baseline, post-treatment 5 days, 1 month, 3 months3
Patient Global Impression of Change (PGI-C)
7-point self-reported instrument that measures a patient's belief about the efficacy of a treatment
Time frame
Post-treatment 5 days, 3 months4
Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Time frame
Baseline, treatment days 1, 2, 3, 4, and 5, post-treatment 5 days, 1 month, 3 monthsOther outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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. Monitored events include: Local effects: headache, scalp discomfort, tinnitus Neurological: seizure, syncope, facial twitching Psychiatric: PTSD exacerbation, suicidality (C-SSRS), mood changes Systemic: fatigue, dizziness Severity 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. SAEs (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.
Time frame
Treatment initiation through 3 months post-treatment (approx. 95 days total)Sponsors and contacts
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Source ClinicalTrials.gov