Optimizing Brain Excitability in Depression
Recruiting · NCT07242105 · Interventional (participants receive a specific treatment) · Lead sponsor: Stanford University
View the official record on ClinicalTrials.gov →Interventions studied
Active Single-Pulse TMSEEG RecordingIntracranial EEG (iEEG) RecordingNon-optimized (Open-Loop) TMSSham Single-Pulse TMSTARGET-optimized TMS
What this trial is about
The goal of this study is to improve depression treatment by establishing reliable prefrontal excitability markers through Targeting with Automated Real-time Guidance for Enhancing TEPs (TARGET).
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men and women, ages 18 to 65
- Diagnosis of major depressive disorder, assessed through a Structured Clinical Interview for DSM-5 (SCID-5)
- In a current depressive episode, assessed through a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (SCID-5)
- Moderate-to-severe depression as indicated by a score between 11-20 on the Quick Inventory of Depressive Symptoms (QIDS)
- Must comprehend English well to ensure adequate comprehension of the EEG and TMS instructions, and of clinical scales
- No current or history of neurological disorders
- No seizure disorder or risk of seizures
- Neurosurgical patients: Men and women ages 18-65 with medication-refractory epilepsy who are admitted for phase II intracranial monitoring to detect a seizure focus will be considered appropriate for this study. Participants must have the intellectual capacity to understand the consent process and agree to the study.
Exclusion criteria
- Those with a contraindication for MRIs (e.g. implanted metal)
- History of head trauma with loss of consciousness
- History of seizures or on medications that reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium)
- Neurological or uncontrolled medical disease
- Any unstable medical condition
- Active substance abuse
- Diagnosis of psychotic or bipolar disorder
- A prior history of Electroconvulsive Therapy (ECT) failure
- History of suicide attempt in the past year
- Currently pregnant or breastfeeding
- Repetitive Transcranial Magnetic Stimulation (rTMS) treatment in the past six months
Where it is running
2 locations listed across 1 US state.
- University of Iowa - Iowa City, California, United States
- Stanford University - Stanford, California, United States