NCT07528157Not yet recruiting
Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression
Early TMS-EEG Potentials as Biomarkers for Personalized Neuromodulation in Treatment-Resistant Depression (R61 Phase)
Source: ClinicalTrials.gov · Last updated 14 Apr 2026
Brief summary (registry, in English)
This study tests whether a brain stimulation treatment for depression called intermittent theta burst stimulation (iTBS) can be improved by tailoring it to each individual. A type of brain signal measured with electroencephalography (EEG) after a single pulse of brain stimulation, called an early local TMS-evoked potential (EL-TEP), is used to identify which stimulation settings work best for each participant. The investigators will compare individualized (personalized) iTBS settings to standard (non-personalized) settings and to inactive (sham) stimulation. Participants are adults with treatment-resistant depression.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Stanford University
- Diseases
- Depression
- NCT number
- NCT07528157
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jun 2026 to the primary completion date, 31 Dec 2027
- 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.
Prior treatment
- Prior exposure to repetitive TMS (rTMS)
- Non-response to electroconvulsive therapy (ECT)
Other illness
- Primary psychiatric diagnosis other than MDD
- Conditions or medications that may increase risk associated with TMS
- History of psychosurgery for depression
Other
- Contraindications to MRI (e.g., implanted metal)
- High suicidal risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Who the study is looking for
- Aged 18-65 years
- Clinical diagnosis of Major Depressive Disorder (MDD), confirmed by structured clinical interview
- Current moderate-to-severe depressive episode (MADRS score ≥ 20)
- Moderate-to-severe treatment resistance, assessed using the Maudsley Staging Method
- Able to comprehend English sufficiently to complete study procedures and assessments
- Able to maintain stable antidepressant regimen or remain medication-free for at least 4 weeks prior to and during the study
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 |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.