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)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Drop-out — From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
  The primary outcome will be drop-out rates
• Treatment completion rates — From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
  The second primary outcome will be treatment completion rates (number of iTBS treatments received out of the planned 20 treatments)

Trial sites (3)

More Aarhus University Hospital trials in Denmark