Mapping how repeated brain stimulation changes neural activity using implanted and scalp recordings
Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans
NA · Stanford University · NCT05996900
This project will test whether repeated transcranial magnetic stimulation (TMS) changes brain activity in people with major depressive disorder or epilepsy by comparing direct recordings from implanted electrodes to noninvasive recordings.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05996900 on ClinicalTrials.gov |
What this trial studies
The study delivers repeated sessions of repetitive TMS while recording brain activity with intracranial electrodes in patients undergoing phase II monitoring for medication-refractory epilepsy and with noninvasive measures. Investigators will characterize the immediate neural response to a single TMS session and how those responses build or change across daily sessions to define plasticity and metaplasticity. Collected invasive and noninvasive electrophysiological signals will be analyzed to identify biomarkers that track stimulation effects and to build computational models linking single-cell plasticity rules to human brain responses. The results will be used to guide more precise TMS targeting and dosing in future clinical applications.
Who should consider this trial
Good fit: Adults 18–65 who are undergoing phase II intracranial monitoring for medication-refractory epilepsy, have the capacity to consent, and no other major neurological disorders are ideal candidates.
Not a fit: People who are not undergoing intracranial monitoring, have MRI contraindications, unstable medical conditions, active substance abuse, or who are pregnant or breastfeeding are unlikely to be eligible or to receive benefit from participating.
Why it matters
Potential benefit: If successful, the work could identify brain signals that help personalize and improve TMS dosing, potentially increasing remission rates for depression and improving stimulation targeting.
How similar studies have performed: TMS is an established treatment for depression and prior small studies have shown physiological brain responses to stimulation, but combining high-resolution invasive recordings with noninvasive measures to map metaplasticity is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women, ages 18 to 65 * Medication-refractory epilepsy requiring phase II monitoring * Must have intellectual capacity to ensure adequate comprehension of the study and potential risks involved in order to provide informed consent * No current or history of major neurological disorders other than epilepsy Exclusion Criteria: * Those with a contraindication for MRIs (e.g. implanted metal) * Any unstable medical condition * Neurological or uncontrolled medical disease * Active substance abuse * Currently pregnant or breastfeeding
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (RECRUITING)
Study contacts
- Study coordinator: Jade Truong
- Email: kellerlab@stanford.edu
- Phone: (408) 840-3313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Disorder, Epilepsy