Accelerated TMS for Treatment-Resistant ECT

NCT07115628 | Recruiting

• 2 other identifiers: EC-2024-380Department of psychiatry
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; MDD; Electroconvulsive therapy; ECT; Transcranial Magnetic Stimulation; TMS

Outcome Measures

Primary Outcomes (1)

• Change in Depression Severity - Clinician-Rated

  Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HDRS-17). Treatment response is defined as a ≥50% reduction in HDRS score from baseline. Remission is defined as an HDRS score ≤7.

  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)

Secondary Outcomes (4)

• Change in Depression Severity - Self-Reported

  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)

• Change in Suicidal Ideation - 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)

• Psychological testing

  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)

• Neuroimaging

  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)

Other Outcomes (2)

• Gut Microbiome Composition

  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)

• Genetic and Epigenetic Biomarkers in Relation to Treatment Response

  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)

Study Arms (1)

TMS

EXPERIMENTAL

dTMS for depressed patients who did not improve after ECT. Patients will receive a 4-day course of active accelerated dTMS (Brainsway H1 coil; 20 sessions in total).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

TMS is a non-invasive brain stimulation technique

Also known as: TMS, adTMS

TMS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Major Depressive Disorder (MDD)
• Age between 18 - 70 years
• Referred for ECT treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Chris Baeken, MD, PhD

CONTACT

+32 2 477 6801; chris.baeken@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 11, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)