Four-day accelerated deep TMS after ECT for severe depression
Accelerated dTMS Treatment for ECT-non Responders
NA · Universitair Ziekenhuis Brussel · NCT07115628
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel (other) |
| Locations | 1 site (Jette, Brussels Capital) |
| Trial ID | NCT07115628 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jette, Brussels Capital
- 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
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.
Conditions: Major Depressive Disorder, MDD, Electroconvulsive therapy, ECT, Transcranial Magnetic Stimulation, TMS