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NOT YET RECRUITING
NCT07693088
NA

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

View on ClinicalTrials.gov

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.

Official title: 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): An Open-label Pilot Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-07

Completion Date

2027-06

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

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.

Locations (3)

Aarhus University Hospital

Aarhus N, Denmark

Regional Psychiatry Horsens

Horsens, Denmark

Regional Psychiatry Central Jutland

Viborg, Denmark