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)

Sponsor
Aarhus University Hospital
Study ID
NCT07693088
Status
Not Yet Recruiting

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Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Intermittent Theta-Burst Stimulation (iTBS) — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 9, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: EMDR with add-on iTBS
    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.

Primary Outcome Measure

Drop-out [ Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks) ]

Central Contacts

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