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)

Aarhus University Hospital

Status: Not yet enrolling

Conditions: PTSD - Post Traumatic Stress Disorder

Treatments: Device: Intermittent Theta-Burst Stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07693088

2502681

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EMDR with add-on iTBS

Experimental group

Description:

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.

Treatment:

Device: Intermittent Theta-Burst Stimulation (iTBS)