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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)

ConditionPTSD - Post Traumatic Stress Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAarhus University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: EMDR with add-on iTBSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Viborg Regional Hospital

Collaborator

Regionshospitalet Horsens

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: