Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Repr… (NCT07693088) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Intermittent Theta-Burst Stimulation (iTBS) as an add-on to Eye Movement Desensitization and Reprocessing (EMDR) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Denmark15 participantsStarted 2026-07
Plain-language summary
This open-label pilot study will evaluate the feasibility, safety, tolerability, and preliminary clinical outcomes of adding intermittent theta-burst stimulation (iTBS) to Eye Movement Desensitization and Reprocessing (EMDR) therapy in adults with post-traumatic stress disorder (PTSD), who show insufficient improvement after an initial course of EMDR.
Participants will receive weekly EMDR therapy. After seven EMDR sessions, treatment response will be assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response will receive add-on iTBS targeted to the right dorsolateral prefrontal cortex (DLPFC) for four weeks while continuing EMDR. Feasibility outcomes include adherence, treatment completion, and dropout rates. Clinical outcomes will include clinician-rated and self-reported measures of PTSD symptoms, depressive symptoms, well-being, and adverse events.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-70 years
* ICD-10 criteria for PTSD (F43.1)
* A minimum total score of 4 (moderately ill) on the Clinical Global Impression-Severity (CGI-S)
* Likely to be able to complete trial participation (16 weeks) without modifications to psychopharmacological treatment, as per the referring doctor's or psychologist's assessment
* Participants must be able and willing to abstain from alcohol consumption during the iTBS treatment period, as required by the TMS Safety Checklist.
Exclusion Criteria:
* Organic mental disorders (F0)
* Currently fulfills the criteria of Active psychoactive substance use or dependence (F1)
* Schizophrenia, schizotypal and delusional disorders (F2), manic episode (F30), or bipolar affective disorder (F31); iv) Mental retardation (estimated IQ \<70, as per the referring doctor's or psychologist's assessment)
* Active suicidality
* Any ongoing involuntary/coercive measures
* Any contraindications listed on the TMS Safety Checklist
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Drop-out
Timeframe: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
2
Treatment completion rates
Timeframe: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)