An interventional study of Intermittent Theta-Burst Stimulation (iTBS) in PTSD - Post Traumatic Stress Disorder, sponsored by Aarhus University Hospital. Not yet recruiting at 3 sites in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Aarhus University Hospital · Not applicable, Interventional, and Treatment
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.
Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by intrusive traumatic memories, avoidance behaviors, negative alterations in cognition and mood, and persistent hyperarousal. Although trauma-focused psychotherapies such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended as first-line treatments, a substantial proportion of patients continue to meet diagnostic criteria for PTSD despite receiving evidence-based psychotherapy.
Intermittent theta-burst stimulation (iTBS), a brief form of repetitive transcranial magnetic stimulation (rTMS), has demonstrated preliminary efficacy in reducing PTSD symptoms and offers practical advantages due to its short treatment duration.
The present study aims to investigate whether iTBS can be feasibly integrated as an adjunctive intervention for patients who do not respond sufficiently to EMDR therapy alone. This is an investigator-initiated, open-label feasibility study conducted within psychiatric services in the Central Denmark Region.
Eligible adults aged 18 to 70 years with a diagnosis of PTSD, who are referred for EMDR treatment, will be enrolled. Participants will receive standardized EMDR therapy consisting of sixteen weekly 90-minute sessions. Following completion of seven EMDR sessions, treatment response will be evaluated using the Clinical Global Impression-Improvement (CGI-I) scale. Participants rated as having insufficient improvement (CGI-I score ≥3) will be offered add-on iTBS.
The iTBS intervention will be delivered to the right DLPFC using a MagPro R30 stimulator and Cool-B70 coil. Treatment will consist of one daily iTBS session administered five days per week over four weeks for a total of 20 sessions. Participants will continue weekly EMDR therapy throughout the iTBS phase and subsequent follow-up period.
The primary objectives are to evaluate the safety, tolerability, and feasibility of the combined EMDR+iTBS intervention. Feasibility outcomes include treatment adherence, treatment completion rates, and dropout rates. Secondary outcomes include adverse events and changes in PTSD symptom severity measured using clinician-rated and self-reported instruments.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 15 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive weekly Eye Movement Desensitization and Reprocessing (EMDR) therapy for up to 16 weeks. After seven EMDR sessions, treatment response is assessed using the Clinical Global Impression-Improvement scale (CGI-I). Participants with insufficient response receive adjunctive intermittent theta-burst stimulation (iTBS) to the right dorsolateral prefrontal cortex for 20 sessions over 4 weeks while continuing EMDR. Participants with sufficient response continue EMDR treatment alone.
Device: Intermittent Theta-Burst Stimulation (iTBS)
All enrolled participants begin standardized EMDR treatment. Participants who show insufficient clinical improvement after seven EMDR sessions receive adjunctive intermittent theta-burst stimulation (iTBS) while continuing EMDR. Participants who show sufficient improvement continue EMDR alone.
Also known as: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
Drop-out
The primary outcome will be drop-out rates
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Treatment completion rates
The second primary outcome will be treatment completion rates (number of iTBS treatments received out of the planned 20 treatments)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by the PTSD Checklist for DSM-5 (PCL-5)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by International Trauma Questionnaire (ITQ)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by the 6-item self-reported Hamilton Depression Rating Scale (HAM-D6-SR)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Adverse event rates, measured by means of the Transcranial Magnetic Stimulation Sensory Questionnaire (TMSens\_Q)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Adverse event rates, measured by means of the Aarhus Side Effects Assessment Scale (ASAQ)
Time frame: Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Changes in mental well-being
Mental well-being as measured by the World Health Organization 5-item well-being scale (WHO-5)
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Plan to share: No
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