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

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ClinicalTrials.gov Identifier: NCT05996900
Recruitment Status : Active, not recruiting
First Posted : August 18, 2023
Last Update Posted : December 6, 2023
Sponsor:
Collaborators:
University of Iowa
Massachusetts General Hospital
Information provided by (Responsible Party):
Corey Keller, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Epilepsy Device: Intracranial electrodes Device: TMS Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Investigating the Neural Mechanisms of Repetitive Brain Stimulation With Invasive and Noninvasive Electrophysiology in Humans
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : July 1, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TBS via direct electrical stimulation Device: Intracranial electrodes
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Active Comparator: TBS via transcranial magnetic stimulation Device: TMS
TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.
Sham Comparator: Sham TBS via direct electrical stimulation Device: Intracranial electrodes
Intracranial electrodes will be used for the delivery of invasive brain stimulation.
Sham Comparator: Sham TBS via transcranial magnetic stimulation Device: TMS
TMS will be used for the delivery of noninvasive brain stimulation both before and after implantation electrode surgery.


Outcome Measures
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Primary Outcome Measures :
  1. TMS-iEEG change after one TBS session [ Time Frame: 45 minutes ]
    Change in evoked response measured after a single TBS session for active and sham, by resting state iEEG (intracranial EEG) and/or sEEG (stereo EEG).


Secondary Outcome Measures :
  1. ES-iEEG change after one TBS session [ Time Frame: 45 minutes ]
    Change in evoked response measured after a single TBS session for active and sham, by resting state iEEG and/or sEEG.

  2. ES-iEEG change between two sequential TBS sessions [ Time Frame: 45 minutes ]
    Change in single-pulse evoked response, or cortico-cortical evoked potentials (CCEPs), measured between two sequential TBS sessions, by resting state iEEG and/or sEEG.

  3. TMS-iEEG change between two sequential TBS sessions [ Time Frame: 45 minutes ]
    Change in single-pulse evoked response, or cortico-cortical evoked potentials (CCEPs), measured between two sequential TBS sessions, by resting state iEEG and/or sEEG.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996900


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Iowa
Massachusetts General Hospital
More Information
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Responsible Party: Corey Keller, Principal Investigator, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT05996900    
Other Study ID Numbers: 11354-1
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders