Four-day accelerated deep TMS after ECT for severe depression
Official title: Accelerated dTMS Treatment for ECT-non Responders
Run by Universitair Ziekenhuis Brussel · NCT07115628 · Data updated 2026-11-12
This project will try a four-day course of accelerated deep TMS (20 sessions) to see if it helps adults with major depressive disorder who did not improve after standard ECT.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette, Brussels Capital) |
| Status | Recruiting |
| Started | October 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | August 11, 2025 |
| Trial ID | NCT07115628 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with a diagnosis of major depressive disorder who are referred for ECT and who do not achieve remission after standard ECT are the intended participants.
✕Probably not a fit
Patients with a personal or close-family history of seizures, certain neurological disorders, metallic cranial implants or other excluded medical conditions, significant cognitive impairment (MMSE <24), or a recent suicide attempt are unlikely to be eligible and may not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients referred for ECT for severe major depressive disorder first receive standard ECT alongside clinical and psychological testing, pre- and post-ECT fMRI, and collection of blood and stool samples. Those who do not reach remission after ECT are offered an interventional phase of accelerated deep transcranial magnetic stimulation (dTMS) given as 20 sessions over four consecutive days. Participants receive a post-dTMS fMRI, repeat clinical and psychological assessments, and further biological sampling to explore predictors of response. The study plans to enroll about 200 patients and will test whether the additional dTMS course increases remission rates and whether imaging, genetic, or microbiome markers relate to outcomes.
Why it matters
Potential benefit: If successful, this approach could provide an effective, rapid follow-up treatment to help ECT non-responders achieve remission from severe depression.
How similar studies have gone: Accelerated and deep TMS approaches have shown promise in treating depression, but applying a 4-day, 20-session dTMS specifically for patients who fail to remit after ECT is relatively novel and not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Major Depressive Disorder (MDD) * Age between 18 - 70 years * Referred for ECT treatment Exclusion Criteria: * A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, abuse substance, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) except dental fill-ings and the presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with some neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with MRI * Patients with cognitive disturbances or dementia (Mini Mental State) \< 24 * Suicide attempt within 6 months before the start of the study or pre-sent risk of suicide per the investigator's clinical judgment
Where it's running
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UZ Brussel
Jette, Brussels Capital, Belgium Recruiting
Study contacts
- Study coordinator: Chris Baeken, MD, PhD
- Email: chris.baeken@uzbrussel.be
- Phone: +32 2 477 6801
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.