NCT07615387Completed
Electrophysiological Biomarkers in Accelerated TMS for Depression
Electrophysiological Biomarkers of Treatment Response in Major Depressive Disorder Patients Receiving Accelerated Transcranial Magnetic Stimulation
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
This study investigates whether physiological signals recorded during transcranial magnetic stimulation (TMS) can predict which patients with major depression respond to treatment. Thirty-two adults with major depressive disorder receive an accelerated TMS protocol targeting the dorsomedial prefrontal cortex using a double-cone coil, delivered as four sessions per day over five to eight days. Heart rate is continuously monitored throughout every stimulation session using a chest-strap sensor, and electroencephalography (EEG) is recorded before and after treatment. Heart-brain coupling was assessed in a separate dedicated session after the target stimulation dose was reached.The primary clinical outcome is the change in depression severity measured by the Hamilton Depression Rating Scale (HAMD-17) from baseline to post-treatment. Prespecified physiological outcomes include stimulation-evoked heart rate deceleration, resting-state EEG parameters, and heart-brain coupling metrics. The aim is to evaluate whether these electrophysiological measures index target engagement and predict antidepressant response, potentially supporting their use as functional biomarkers for personalizing accelerated TMS in depression.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 32 (actual)
- First submitted
- 18 May 2026
- Start date
- 13 Jun 2024
- Primary completion date
- 14 Mar 2025
- Lead sponsor
- Istanbul University - Cerrahpasa
- Diseases
- Depression
- NCT number
- NCT07615387
What you commit to
- Study type: Interventional
- Participants enrolled: 32
- From 13 Jun 2024 to the primary completion date, 14 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac arrhythmia or use of antiarrhythmic medication
- Comorbid psychiatric disorders other than anxiety disorders (including bipolar disorder, psychotic disorders, substance use disorders, and primary obsessive-compulsive disorder)
- Standard contraindications to transcranial magnetic stimulation, including history of seizure, intracranial metal implants, cochlear implants, or implanted neurostimulators
- Severe or unstable medical illness
Other
- Benzodiazepine use exceeding the equivalent of 1 mg/day lorazepam
- Active suicidal ideation
- Pregnancy
Who the study is looking for
- Adults aged 18 to 65 years
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder, of at least moderate severity, confirmed by structured psychiatric interview
- Insufficient response to at least one adequate trials of antidepressant pharmacotherapy during the current episode
- Stable psychotropic medication regimen for at least 4 weeks prior to enrollment
- Ability to provide written informed consent
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istanbul University-Cerrahpaşa Cerrahpaşa Medical Faculty Psychiatry Department Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.