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)
1 other identifier
interventional
15
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
July 9, 2026
July 1, 2026
11 months
June 16, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Drop-out
The primary outcome will be drop-out rates
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)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Secondary Outcomes (7)
Symptom trajectories
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
- +2 more secondary outcomes
Study Arms (1)
EMDR with add-on iTBS
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospitallead
- Viborg Regional Hospitalcollaborator
- Regionshospitalet Horsenscollaborator
Study Sites (3)
Aarhus University Hospital
Aarhus N, Denmark
Regional Psychiatry Horsens
Horsens, Denmark
Regional Psychiatry Central Jutland
Viborg, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pernille Kølbæk
Aarhus University Hospital
- PRINCIPAL INVESTIGATOR
Ana Lisa Carmo
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Regional Clinical Research Coordinator, Associate professor
Study Record Dates
First Submitted
June 16, 2026
First Posted
July 9, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
July 9, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share