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Recruiting NCT05996900

Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans

No phase Interventional Major Depressive Disorder Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracranial electrodes, TMS.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Epilepsy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Transcranial magnetic stimulation (TMS) is an effective treatment for depression, but clinical outcome is suboptimal, partially because investigators are missing biologically-grounded brain markers which show that TMS is modifying activity at the intended target in the brain. The goal of this proposal is to characterize the key markers of the brain's response to repeated doses of TMS with high resolution using invasive brain recordings in humans, and relate these brain markers to noninvasive recordings. These markers will improve the understanding of TMS and can be used to optimize and enhance clinical efficacy for depression and other psychiatric disorders.

Detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an effective treatment for major depressive disorder, but remission rates are 20-40%, and ideal stimulation parameters are unknown. rTMS is thought to work by changing the synaptic strength of neurons. The ability of the brain to make these changes is referred to as plasticity. rTMS-induced changes are thought to build with successive treatment sessions, a process referred to as metaplasticity. While both plasticity and metaplasticity are well-established in single cell physiology, relevance to rTMS in humans remains unknown. To improve clinical efficacy, the investigators need to understand 1) the neural response to a single rTMS session (plasticity), 2) the neural response to repeated daily rTMS sessions (metaplasticity), and 3) whether computational models of plasticity based on single-cell physiology apply to human patients receiving rTMS for depression.

Goals of the study are to 1) establish a detailed mechanistic understanding of the brain changes during current rTMS treatment; 2) identify clinically meaningful electrophysiological biomarkers for rTMS treatment; 3) establish a computational model to help predict both brain and clinical changes.

Interventions

  • Device Intracranial electrodes
    Intracranial electrodes will be used for the delivery of invasive brain stimulation.
  • Device TMS
    TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.

Primary outcome measures

  • TMS-iEEG change after one TBS session [Time frame: 45 minutes]
Secondary outcome measures (3)
  • ES-iEEG change after one TBS session [Time frame: 45 minutes]
  • ES-iEEG change between two sequential TBS sessions [Time frame: 45 minutes]
  • TMS-iEEG change between two sequential TBS sessions [Time frame: 45 minutes]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Stanford University — Stanford

Identifiers

NCT: NCT05996900 · 11354-1 · 1R01MH132074

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗