Recruiting

Accelerated TMS for Treatment-Resistant ECT

ClinicalTrials.gov IDNCT07115628

PhaseNA

Enrollment200

SponsorUniversitair Ziekenhuis Brussel

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Major Depressive Disorder (MDD)

About this study

This study investigates whether an additional treatment using transcranial magnetic stimulation (TMS) can help severely depressed patients who did not respond well to electroconvulsive therapy (ECT). All participants will first receive standard ECT treatment for depression, including brain scans (fMRI), psychological testing, clinical assessments, and the collection of blood and stool samples. If the ECT treatment is not effective, patients will be invited to participate in a second part of the study where they receive a 4-day course of accelerated TMS (20 sessions in total). The study aims to assess whether this additional TMS treatment can reduce depressive symptoms. The study also explores how brain structure, genetics, and gut health may relate to treatment success. In total, 200 patients will be included.

Interventions

Device: Transcranial Magnetic Stimulation — TMS is a non-invasive brain stimulation technique

Primary outcomes

Change in Depression Severity - Clinician-Rated (Baseline (within 1 week before first ECT); within 1 week after last ECT session (variable duration); within 1 week after adTMS (20 sessions over 4 days; ECT non-responders only))

Eligibility information

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

Study locations

UZ Brussel, Jette, Brussels Capital 1090 Belgium

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.