PTSD - Post Traumatic Stress DisorderNCT07693088
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)
A study testing Intermittent Theta-Burst Stimulation (iTBS) in people with PTSD - Post Traumatic Stress Disorder, run by Aarhus University Hospital at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Intermittent Theta-Burst Stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesDenmark
- Study dates
- Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites
Aarhus University Hospital
Aarhus N
Pernille Kølbæk, MD PhD, 004561397432, perpet@rm.dk
Ana Lisa Carmo, Psychiatrist, 0045 61155056, ANAMAR@rm.dk
Regional Psychiatry Horsens
Horsens
Thea Grønfeldt, Psychiatrist, 00457847 9258, theafaer@rm.dk
Pernille Kølbæk, MD PhD, 004561397432, perpet@rm.dk
Regional Psychiatry Central Jutland
Viborg
Ana Lisa Carmo, Psychiatrist, 004561155056, ANAMAR@rm.dk
Pernille Kølbæk, MD PhD, 004561397432, perpet@rm.dk
About this study
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
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.
Read the 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.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Intermittent Theta-Burst Stimulation (iTBS)
- Keywords
- Eye Movement Desensitization Reprocessing, Transcranial Magnetic Stimulation, Intermittent Theta-Burst Stimulation (iTBS), Post-Traumatic Stress Disorder
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta-Burst Stimulation (iTBS)Device
Also called Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
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 group | Role | What they receive |
|---|---|---|
| EMDR with add-on iTBS | Experimental | 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. Receives: Device: Intermittent Theta-Burst Stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop-out
The primary outcome will be drop-out rates
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Treatment completion rates
The second primary outcome will be treatment completion rates (number of iTBS treatments received out of the planned 20 treatments)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Secondary outcomes (7)
Symptom trajectories
Symptom trajectories, as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by the PTSD Checklist for DSM-5 (PCL-5)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by International Trauma Questionnaire (ITQ)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Symptom trajectories
Symptom trajectories, as measured by the 6-item self-reported Hamilton Depression Rating Scale (HAM-D6-SR)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Adverse event rates, measured by means of the Transcranial Magnetic Stimulation Sensory Questionnaire (TMSens_Q)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Adverse event rates
Adverse event rates, measured by means of the Aarhus Side Effects Assessment Scale (ASAQ)
Measured: Time Frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Changes in mental well-being
Mental well-being as measured by the World Health Organization 5-item well-being scale (WHO-5)
Measured: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Viborg Regional Hospital, Regionshospitalet Horsens
- Responsible party
- Principal investigator, Pernille Kølbæk, Aarhus University Hospital
- Investigators
- Pernille Kølbæk, Study chair, Aarhus University HospitalAna Lisa Carmo, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693088
- Sponsor's protocol ID
- 2502681
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07693088
- Acronym / sponsor ID
- 2502681
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- Eye Movement Desensitization Reprocessing, Transcranial Magnetic Stimulation, Intermittent Theta-Burst Stimulation (iTBS), Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Viborg Regional Hospital, Regionshospitalet Horsens
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMDR with add-on iTBS | Experimental | Device: Intermittent Theta-Burst Stimulation (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Theta-Burst Stimulation (iTBS)Also: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)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. | Device | EMDR with add-on iTBS |
Primary outcome
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
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)
7 secondary outcomes
Symptom trajectories
Time frame: 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
Time frame: 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)
Adverse event rates
Time frame: 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)
Changes in mental well-being
Time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for PTSD - Post Traumatic Stress Disorder
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pernille Kølbæk study chair
Aarhus University Hospital
Ana Lisa Carmo principal investigator
Aarhus University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta-Burst Stimulation (iTBS) in people with PTSD - Post Traumatic Stress Disorder, run by Aarhus University Hospital at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pernille Kølbæk, MD PhD (004561397432, perpet@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop-out (time frame: From initiation of iTBS to completion of the 4-week iTBS treatment period (approximately 4 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.