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)

July 7, 2026 updated by: Pernille Kølbæk, Aarhus University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Post-traumatic stress disorder (PTSD) is a disabling psychiatric condition characterized by intrusive traumatic memories, avoidance behaviors, negative alterations in cognition and mood, and persistent hyperarousal. Although trauma-focused psychotherapies such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended as first-line treatments, a substantial proportion of patients continue to meet diagnostic criteria for PTSD despite receiving evidence-based psychotherapy.

Intermittent theta-burst stimulation (iTBS), a brief form of repetitive transcranial magnetic stimulation (rTMS), has demonstrated preliminary efficacy in reducing PTSD symptoms and offers practical advantages due to its short treatment duration.

The present study aims to investigate whether iTBS can be feasibly integrated as an adjunctive intervention for patients who do not respond sufficiently to EMDR therapy alone. This is an investigator-initiated, open-label feasibility study conducted within psychiatric services in the Central Denmark Region.

Eligible adults aged 18 to 70 years with a diagnosis of PTSD, who are referred for EMDR treatment, will be enrolled. Participants will receive standardized EMDR therapy consisting of sixteen weekly 90-minute sessions. Following completion of seven EMDR sessions, treatment response will be evaluated using the Clinical Global Impression-Improvement (CGI-I) scale. Participants rated as having insufficient improvement (CGI-I score ≥3) will be offered add-on iTBS.

The iTBS intervention will be delivered to the right DLPFC using a MagPro R30 stimulator and Cool-B70 coil. Treatment will consist of one daily iTBS session administered five days per week over four weeks for a total of 20 sessions. Participants will continue weekly EMDR therapy throughout the iTBS phase and subsequent follow-up period.

The primary objectives are to evaluate the safety, tolerability, and feasibility of the combined EMDR+iTBS intervention. Feasibility outcomes include treatment adherence, treatment completion rates, and dropout rates. Secondary outcomes include adverse events and changes in PTSD symptom severity measured using clinician-rated and self-reported instruments.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pernille Kølbæk, MD PhD
  • Phone Number: 004561397432
  • Email: perpet@rm.dk

Study Contact Backup

  • Name: Ana Lisa Carmo, Psychiatrist
  • Phone Number: 0045 61155056
  • Email: ANAMAR@rm.dk

Study Locations

  • Denmark
      • Aarhus N, Denmark
        • Aarhus University Hospital
        • Contact:
          • Pernille Kølbæk, MD PhD
          • Phone Number: 004561397432
          • Email: perpet@rm.dk
        • Contact:
          • Ana Lisa Carmo, Psychiatrist
          • Phone Number: 0045 61155056
          • Email: ANAMAR@rm.dk
        • Principal Investigator:
          • Ana Lisa Carmo, Psychiatrist
      • Horsens, Denmark
        • Regional Psychiatry Horsens
        • Contact:
          • Pernille Kølbæk, MD PhD
          • Phone Number: 004561397432
          • Email: perpet@rm.dk
        • Contact:
          • Thea Grønfeldt, Psychiatrist
          • Phone Number: 00457847 9258
          • Email: theafaer@rm.dk
        • Principal Investigator:
          • Pernille Kølbæk, MD PhD
      • Viborg, Denmark
        • Regional Psychiatry Central Jutland
        • Contact:
          • Pernille Kølbæk, MD PhD
          • Phone Number: 004561397432
          • Email: perpet@rm.dk
        • Principal Investigator:
          • Ana Lisa Carmo, Psychiatrist
        • Contact:
          • Ana Lisa Carmo, Psychiatrist
          • Phone Number: 004561155056
          • Email: ANAMAR@rm.dk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom trajectories
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories, as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories, as measured by the PTSD Checklist for DSM-5 (PCL-5)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories, as measured by International Trauma Questionnaire (ITQ)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories, as measured by the 6-item self-reported Hamilton Depression Rating Scale (HAM-D6-SR)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates, measured by means of the Transcranial Magnetic Stimulation Sensory Questionnaire (TMSens_Q)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Time Frame: Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates, measured by means of the Aarhus Side Effects Assessment Scale (ASAQ)
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Changes in mental well-being
Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Mental well-being as measured by the World Health Organization 5-item well-being scale (WHO-5)
From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Collaborators

Regionshospitalet Horsens
Viborg Regional Hospital

Investigators

  • Study Chair: Pernille Kølbæk, Aarhus University Hospital
  • Principal Investigator: Ana Lisa Carmo, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2502681

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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