Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to determine whether particular forms of brain-stimulation, applied to superior frontal cortex/preSMA can affect cognition and associated frontal theta oscillations. To perform this study, the investigators first measure brain activity and cognitive performance using "BrainE", a cognitive task platform that assesses cognition on sustained attention, response inhibition, working memory, interference processing and emotion processing assessments. Next, the investigators apply brain-stimulation over a mid-frontal region associated with these tasks (mid-line frontal activity overlying superior frontal cortex/pre-SMA area). Finally, human subjects perform the "BrainE" task assessments again immediately after the brain-stimulation. The investigators compare the effects of brain stimulation on average frontal activity evoked across the cognitive tasks, and on the cognitive performance averaged across tasks. The investigators primarily compare the effects of two types of brain-stimulation against each other: intermittent Theta-Burst Stimulation (a protocol designed to excite brain activity) and continuous Theta-Burst-Stimulation (a stimulation protocol designed to inhibit brain activity).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS then cTBS | Experimental | Participants in this arm first receive the iTBS brain stimulation in week 1, then have a one-week washout period and then receive cTBS brain stimulation in week 2. intermittent Theta-Burst-Stimulation (iTBS) entails a 2 second train of stimuli (stimuli occurring as a 50 Hz burst of three pulses separated by 200ms). Each 2 second train is followed by an 8 second pause, followed by another 2 second train. In total, 20 trains will be delivered, for a total of 200 bursts and 600 total pulses. continuous Theta-Burst-Stimulation (cTBS) consists of a continuous stimulus train (stimuli occurring as a 50 Hz burst of three pulses separated by 200ms). In total, 200 bursts and 600 total pulses will be delivered. |
|
| cTBS then iTBS | Experimental | Participants in this arm first receive the cTBS brain stimulation in week 1, then have a one-week washout period and then receive iTBS brain stimulation in week 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS then cTBS | Device | repetitive transcranial magnetic stimulation applied with intermittent theta-burst stimulation protocol applied in week 1 and continuous theta-burst stimulation protocol applied in week 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation | Change in superior frontal stimulus-evoked theta oscillations were measure on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The evoked EEG response (mid-frontal theta FCz as a source for superior frontal theta) was averaged across all cognitive tasks to yield a global cognitive task-averaged signal that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS. | (Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart. |
| Measure | Description | Time Frame |
|---|---|---|
| Post vs. Pre Change in Cognitive Performance | Change in cognitive performance was measured on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The cognitive performance was averaged across all cognitive tasks to yield global cognitive task-averaged performance that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS. |
Not provided
Inclusion Criteria:
Adequate decisional capacity to make a choice about participating in this research study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jyoti Mishra, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical & Translational Research Institute | La Jolla | California | 92037 | United States |
No enrolled participants were excluded.
Participants were screened for this study prior to enrollment. Any individuals with a history of seizure disorder; vascular or other lesion of the brain; administration of drugs that lower the seizure threshold; implanted or non-removable metallic objects above the neck; implanted devices with electrical circuits were excluded from enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | cTBS Then iTBS | Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)cTBS versus (Post-Pre)iTBS |
| FG001 | iTBS Then cTBS | Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day). The global cognitive task-average superior frontal theta signal was calculated as (Post - Pre)iTBS versus (Post-Pre)cTBS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | cTBS Then iTBS | Participants received cTBS at week 1 (1 day), washout (1 week) then iTBS at week 2 (1 day). |
| BG001 | iTBS Then cTBS | Participants received iTBS at week 1 (1 day), washout (1 week) then cTBS at week 2 (1 day). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post vs. Pre Change in Mid-frontal Theta Oscillations for iTBS vs. cTBS Stimulation | Change in superior frontal stimulus-evoked theta oscillations were measure on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The evoked EEG response (mid-frontal theta FCz as a source for superior frontal theta) was averaged across all cognitive tasks to yield a global cognitive task-averaged signal that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS. | Although 25 participants enrolled, only 24 completed the study. | Posted | Mean | Standard Deviation | microVolts (uV) at FCz EEG electrode | (Post-Pre) iTBS and (Post-Pre) cTBS signals were measured one week apart. |
|
one week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | cTBS | Participants received cTBS intervention in one of the two study visits. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jyoti Mishra | University of California San Diego | 8582322855 | jymishra@ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2021 | Feb 16, 2021 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
The investigators will test the effects of two different interventions (iTBS, cTBS) on cognitive control. Each participant will receive both interventions, labeled A & B, separated a week apart.
Not provided
Not provided
Investigators will assess for each subject whether they have any guess, a priori, as to hypothesized effects of the iTBS vs. cTBS protocols (improve, impair or no change on cognition). Participant/care provider will know which stimulation is being applied (iTBS, cTBS based on labels A & B), but will not know the hypothesized effects of these two protocols. iTBS and cTBS protocols will be masked as "treatment A" and "treatment B", prior to handing the data over to PI/outcomes assessor. Analyses will thus be performed to assess whether treatment "A" or treatment "B" has an effect on cognition; and whether there are differences between these treatment protocols.
| cTBS then iTBS | Device | repetitive transcranial magnetic stimulation applied with continuous theta-burst stimulation protocol applied in week 1 and intermittent theta-burst stimulation protocol applied in week 2. |
|
| (Post-Pre) iTBS and (Post-Pre) cTBS cognitive performance levels were measured one week apart. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | iTBS | The participants received iTBS intervention in one of the two study visits. The global cognitive task-average FCz theta signal was calculated as (Post-Pre)iTBS. |
|
|
| Secondary | Post vs. Pre Change in Cognitive Performance | Change in cognitive performance was measured on a set of cognitive tasks, specifically selective attention, response inhibition, working memory, interference processing and emotion processing tasks. The cognitive performance was averaged across all cognitive tasks to yield global cognitive task-averaged performance that was measured immediately before (Pre) and immediately after (Post) iTBS, and similarly immediately before (Pre) and immediately after (Post) cTBS. | Although 25 participants enrolled, only 24 completed the study. | Posted | Mean | Standard Deviation | log(1/sec) | (Post-Pre) iTBS and (Post-Pre) cTBS cognitive performance levels were measured one week apart. |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | iTBS | Participants received iTBS intervention in one of the two study visits. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
Not provided