Health TrialsbyHealthPanel

Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression

ConditionsMajor Depressive DisorderTreatment Resistant Depression
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Primary psychiatric diagnosis other than MDD

Contraindications to MRI (e.g., implanted metal)

Conditions or medications that may increase risk associated with TMS

Prior exposure to repetitive TMS (rTMS)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Personalized iTBS

    Device

    Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex using individualized pulse count (600, 1200, or 1800 pulses) and intensity (90% or 120% rMT) determined by EL-TEP screening.

  • Non-Personalized iTBS

    Device

    Intermittent theta burst stimulation delivered to the left dorsolateral prefrontal cortex at fixed parameters: 1800 pulses, 120% resting motor threshold.

  • Sham iTBS

    Device

    Inactive sham stimulation using a shielded coil with electrical scalp stimulation to mimic sensory experience of active iTBS.

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: Personalized iTBSExperimental treatment 1 intervention
Group B: Non-Personalized iTBSActive comparator 1 intervention
Group C: Sham iTBSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change in Early Local TMS-Evoked Potential (EL-TEP) Amplitude

EL-TEP amplitude is the peak-to-trough amplitude of the early (20-60 ms) EEG response recorded over the left dorsolateral prefrontal cortex following single TMS pulses. Percent change is calculated from pre-iTBS to post-iTBS for each stimulation condition.

Time frame
Baseline, end of 10 iTBS sessions within a single testing day (10 hours)

Secondary outcomes

1

Acute EL-TEP Suppression Following Each Screened iTBS Condition

Percent change in EL-TEP amplitude from before to after each of the six screened iTBS parameter combinations during the screening phase.

Time frame
Baseline, end of each iTBS session during the screening phase (3 screening days, up to approximately 3 weeks)
2

Trajectory of EL-TEP Change Across Multiple Sessions Within a Testing Day

EL-TEP amplitude measured before and after sessions 1, 2, 3, and 10 on each testing day to characterize cumulative effects.

Time frame
Baseline, before and after sessions 1, 2, 3, and 10 within a single testing day (10 hours)
3

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

Clinician-administered scale assessing depressive symptom severity. Score range: 0-60 (higher scores indicate greater severity).

Time frame
Baseline, end of each testing day (up to approximately 7 weeks)
4

Change in Quick Inventory of Depressive Symptomatology (QIDS) Score

Self-report measure of depressive symptom severity. Score range: 0-27 (higher scores indicate greater severity).

Time frame
Baseline, end of each testing day (up to approximately 7 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: