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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to evaluate the causal link between the phase of ongoing theta oscillations in the prefrontal cortex and approach/avoidance (Ap/Av) behavior in adults using theta phase-specific transcranial magnetic stimulation (TMS).
Approach/avoidance (Ap/Av) behavior is a reliable marker of the emotional processes in the human brain and a robust predictor of mood disorders. Although existing scientific studies found a correlation between the approach/avoidance behavior and ongoing theta activity (3-7 Hz) in the left dorsolateral prefrontal cortex, the causal evidence of the phase-dependent role and strength of association between the prefrontal theta oscillations and approach/avoidance behavior are still unclear. Here, we will monitor brain oscillations in real-time non-invasively using electroencephalography during the approach/avoidance test and modulate theta peaks or troughs with transcranial magnetic stimulation. These data will provide novel understanding of the mechanisms of emotional processing in human brain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS over the left prefrontal cortex | Experimental | Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the left dorsolateral prefrontal cortex (DLPFC) at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing and stimulation per session is approximately 40 minutes (in 4 blocks with breaks in-between). |
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| TMS over the head vertex | Sham Comparator | Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation (TMS) | Device | TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG). |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Times in the Approach/Avoidance Test | Reaction time (in milliseconds) in the Approach/Avoidance task during transcranial magnetic stimulation (TMS). TMS was synchronized to either the peaks or troughs of the participant's left prefrontal theta waves, in a randomized and counterbalanced order. The preregistered primary outcome measure is the average difference in reaction times between peak- and trough-synchronized stimulation stimuli. This statistical contrast specifically highlights the role of theta phase in phase-aligned stimulation. | During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition). |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude of TMS Evoked Potentials | Amplitude of transcranial magnetic stimulation (TMS)-evoked potentials (in microvolts) in ongoing electroencephalography (EEG) in the left prefrontal cortex during the TMS synchronized to either peaks or troughs of the participant's left prefrontal theta waves. The preregistered secondary outcome measure is the average difference in early absolute evoked potentials between peak- and trough-synchronized stimulation epochs. This statistical contrast specifically highlights the phase-specific effect of theta phase-aligned stimulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Opitz, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Full or partial access to the preprocessed data will be provided upon the request to the faculty / research staff of recognized research, medical, and educational institutions for educational and scientific purposes. The request should be sent via an institutional email and will be stored with the study materials. The request should include a short description of the scientific or educational aims.
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Data will be shared only upon request after the study has ended (within 6 months).
To receive access, the study investigators need to be contacted via an institutional e-mail including a short description of the scientific or educational aims.
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| ID | Title | Description |
|---|---|---|
| FG000 | TMS Over the Prefrontal Cortex Followed by TMS Over the Head Vertex. | Transcranial magnetic stimulation (TMS) was first applied to the left dorsolateral prefrontal cortex (Condition 1) and then to the vertex of the head (Condition 2) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs. |
| FG001 | TMS Over the Head Vertex Followed by TMS Over the Prefrontal Cortex. | Transcranial magnetic stimulation (TMS) was first applied to the vertex of the head (Condition2) and then to the left dorsolateral prefrontal cortex (Condition 1) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, participants performed the Approach/Avoidance task, which included the presentation of emotional stimuli. Each stimulus was accompanied by a simultaneous burst of TMS pulses, synchronized to either the peaks or troughs of the participant's left prefrontal theta waves (in randomized, interleaved order). Participants responded to each stimulus with a joystick movement (which should have been either congruent or incongruent as per the task hint, in randomized, interleaved order). The primary outcome measure was the difference in responses during TMS synchronized to theta wave peaks versus troughs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All 26 participants consented in this study |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Reaction Times in the Approach/Avoidance Test | Reaction time (in milliseconds) in the Approach/Avoidance task during transcranial magnetic stimulation (TMS). TMS was synchronized to either the peaks or troughs of the participant's left prefrontal theta waves, in a randomized and counterbalanced order. The preregistered primary outcome measure is the average difference in reaction times between peak- and trough-synchronized stimulation stimuli. This statistical contrast specifically highlights the role of theta phase in phase-aligned stimulation. | Cross-over study - all participants were in both arms at different timepoints | Posted | Median | Standard Error | milliseconds | During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition). |
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During the visit that included TMS procedures (4 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TMS Over the Prefrontal Cortex Followed by TMS Over the Head Vertex. | Transcranial magnetic stimulation was first applied to the left dorsolateral prefrontal cortex (condition 1) and then to the head vertex (condition 2) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, the brain state during the stimulation (peaks vs. troughs of the participant's prefrontal theta wave) and the task stimuli (congruent vs. incongruent) were randomized and counterbalanced. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Opitz | University of Minnesota | 612-624-1094 | aopitz@umn.edu |
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| 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 | Sep 14, 2024 | Aug 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 1, 2023 | Sep 16, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition). |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | TMS Over the Head Vertex | Transcranial magnetic stimulation (TMS) will be administrated with a figure-8 coil over the head vertex at the intensity of up to 120% of the individualized resting motor threshold (rMT). Stimulation will be performed during and for the duration of the cognitive test. Up to three TMS pulses will be delivered at the beginning of every test trial (each trial duration is 2-6 seconds). The total duration of the cognitive testing per session is approximately 40 minutes (in 4 blocks with breaks in-between). Transcranial magnetic stimulation (TMS): TMS will be performed at either peaks or troughs of ongoing prefrontal theta oscillations (3-7 Hz) concurrently with the cognitive test at the beginning of every test trial. Theta oscillations will be monitored in real-time at the left dorsolateral prefrontal cortex using electroencephalography (EEG). |
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| Secondary | Amplitude of TMS Evoked Potentials | Amplitude of transcranial magnetic stimulation (TMS)-evoked potentials (in microvolts) in ongoing electroencephalography (EEG) in the left prefrontal cortex during the TMS synchronized to either peaks or troughs of the participant's left prefrontal theta waves. The preregistered secondary outcome measure is the average difference in early absolute evoked potentials between peak- and trough-synchronized stimulation epochs. This statistical contrast specifically highlights the phase-specific effect of theta phase-aligned stimulation. | Posted | Mean | Standard Deviation | microvolts | During the stimulation/task for each condition (approximately 6 minutes per run, 4 runs per condition). |
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| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | TMS Over the Head Vertex Followed by TMS Over the Prefrontal Cortex. | Transcranial magnetic stimulation was first applied to the head vertex (condition 2) and then to the left dorsolateral prefrontal cortex (condition 1) at an intensity of up to 120% of the individualized resting motor threshold. During both conditions, the brain state during the stimulation (peaks vs. troughs of the participant's prefrontal theta wave) and the task stimuli (congruent vs. incongruent) were randomized and counterbalanced. | 0 | 12 | 0 | 12 | 0 | 12 |
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