Right-sided low-frequency (1-Hz) rTMS versus left-sided intermittent theta-burst stimulation for depression
Right-sided 1-Hz Repetitive Transcranial Magnetic Stimulation (rTMS) Versus Left-sided Intermittent Theta Burst Stimulation (iTBS) in Patients With Depression. -a Randomized Non-inferiority Trial
This trial will test whether right-sided low-frequency (1-Hz) rTMS works as well as left-sided iTBS for adults with unipolar or bipolar depression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Örebro County Academic / other |
| Locations | 2 sites (Örebro and 1 other locations) |
| Trial ID | NCT07026461 on ClinicalTrials.gov |
What this trial studies
This national, register-based, randomized, unmasked non-inferiority trial in Sweden compares two rTMS protocols—right-sided inhibitory 1-Hz stimulation and left-sided intermittent theta-burst stimulation (iTBS)—delivered to the dorsolateral prefrontal cortex in adults with unipolar or bipolar depression. Participants are randomized to one of two treatment arms and receive a course of rTMS at brain stimulation units in Örebro or Uppsala. The primary outcome is change in self-rated Montgomery-Åsberg Depression Rating Scale (MADRS-S) from baseline to end of treatment, with secondary outcomes including clinician-rated CGI-Improvement, response defined as ≥50% reduction in MADRS-S, and health-related quality of life (EQ-5D VAS). The trial is phase 4 and aims to show whether the simpler right-sided 1-Hz approach is not worse than iTBS for reducing depressive symptoms.
Who should consider this trial
Good fit: Adults (≥18 years) with a clinical ICD-10 diagnosis of unipolar or bipolar depression who accept rTMS, have a Swedish personal identity number, and can give informed consent are ideal candidates.
Not a fit: Patients for whom one of the two protocols is judged inappropriate by the investigator, those with contraindications to rTMS, people under 18, or those unable to attend the Swedish treatment sites are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, it could expand effective rTMS options by showing a simpler right-sided 1-Hz protocol is as effective as iTBS, offering another accessible treatment approach for depressive episodes.
How similar studies have performed: Previous trials have shown both iTBS and low-frequency right-sided rTMS can be effective for depression and iTBS has been shown non-inferior to standard left high-frequency rTMS, but direct randomized non-inferiority comparisons between right 1-Hz and left iTBS are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age at the time of inclusion. * A clinical diagnosis of unipolar or bipolar depression according to ICD-10. * Acceptance of rTMS. * A Swedish personal identity number. * Capable of giving informed consent. Exclusion Criteria: • If the investigator judges one of the two treatment protocols inappropriate for the patient.
Where this trial is running
Örebro and 1 other locations
- Unit for Brainstimulation — Örebro, Sweden (Recruiting)
- Unit for Brainstimulation — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Robert Bodén, MD, PhD — Uppsala University, Region Uppsala County
- Study coordinator: Axel Nordenskjöld, MD,PhD
- Email: axel.nordenskjold@regionorebrolan.se
- Phone: +46196021000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.