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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder Epilepsy | Device: Intracranial electrodes Device: TMS | Not Applicable |
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 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 |
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. |
- 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).
- 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.
- 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.
- 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.
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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 |
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
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
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 |
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 |
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 |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders |