An interventional study of Transcranial magnetic stimulation task and Sham transcranial magnetic stimulation task in Emotion Regulation and Real Versus Sham Transcranial Magnetic Stimulation (TMS), sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
Distancing oneself from a current distressing situation is a mental skill that can help people to manage their emotions. However, little is known about how distancing works in the brain. Recently developed tools in neuroscience that can modify brain activity might be able to make distancing more or less effective. In doing so, the results could lead to a better understanding of the cognitive processes and neural circuits that support distancing as a form of emotion regulation. If successful, this research may lead to the development of new treatments to help those who suffer from stress-related disorders, such as anxiety and depression.
Distancing is an emotion regulation skill that relies in part on self-projection, or the ability to shift perspective from the here and now to a simulated time, place, or person. Based on prior review and meta-analysis of the distancing literature, a new model has been developed of the neurocognitive processes that support distancing. The proposed experiment will test the model causally through a neural intervention that should impair or enhance the ability of healthy adults to successfully apply distancing to down-regulate negative affect. In the model, it is hypothesized that the temporoparietal junction (TPJ) was a key region mediating the self-projection aspect of distancing. Leveraging recent functional magnetic resonance imaging (fMRI) work, the experiment will functionally modulate this region through inhibitory transcranial magnetic stimulation (TMS) to test its causal role in distancing. Importantly, the proposed work shifts emphasis from traditional models of emotion regulation, which implicate frontal executive control mechanisms, to new cognitive processes and brain targets that can ultimately lead to novel approaches to treat affective disorders.
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Exclusion Criteria:
Subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to:
Intracranial implants, such as:
Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task. Thirty minutes after stimulation, experimenters will employ a sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.
Device: Transcranial magnetic stimulation task
Experimenters will employ a sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject. Experimenters have defined the target coordinates for the stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task. Thirty minutes post sham stimulation, experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates.
Device: Sham transcranial magnetic stimulation task
Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.
Also known as: TMS
A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.
Also known as: Sham TMS
Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.
Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distancing) when shown graphic stimuli.
Time frame: baseline, 30 minutes post stimulation
Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation.
Effort is how difficult it was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distancing) when shown graphic stimuli.
Time frame: baseline, 30 minutes post stimulation
Change in Self-reported Valence (Distraction) From Baseline to 30 Minutes Post Stimulation.
Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distraction) when shown graphic stimuli.
Time frame: baseline, 30 minutes post stimulation
Change in Self-reported Effort (Distraction) From Baseline to 30 Minutes Post Stimulation.
Effort is how difficult is was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distraction) when shown graphic stimuli.
Time frame: baseline, 30 minutes post stimulation
Subjects were recruited from 11/1/18 until 5/17/19. Subjects were recruited and screened from the Duke University Brain Imaging Analysis Center (BIAC) research participant pool as well as from e-flyers on Duke University's electronic community bulletin board (DukeList).
| Milestone | Transcranial Magnetic Stimulation (TMS), Then Sham TMS | Sham TMS, Then Transcranial Magnetic Stimulation (TMS) |
|---|---|---|
| Started | 20 | 20 |
| Completed | 15 | 15 |
| Not completed | 5 | 5 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Failed drug screen | 1 | 1 |
| Withdrew: Failed health screen | 0 | 1 |
| Withdrew: Ineligible for financial compensation | 1 | 0 |
| Withdrew: Equipment error | 1 | 0 |
| Withdrew: Could not establish tms dosage | 0 | 1 |
Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distancing) when shown graphic stimuli.
| score on a scale | Transcranial Magnetic Stimulation (TMS) | Sham TMS |
|---|---|---|
| Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation. | .662 ± .565 | .668 ± .561 |
Effort is how difficult it was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distancing) when shown graphic stimuli.
| score on a scale | Transcranial Magnetic Stimulation (TMS) | Sham TMS |
|---|---|---|
| Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation. | 3.610 ± .841 | 3.546 ± .959 |
Valence is how positive or negative a subject feels. Subjects will be asked to rate how they feel on a 7 point Likert scale ranging from 1 (very negative) to 7 (very positive) after using an emotion regulation technique (distraction) when shown graphic stimuli.
| score on a scale | Transcranial Magnetic Stimulation (TMS) | Sham TMS |
|---|---|---|
| Change in Self-reported Valence (Distraction) From Baseline to 30 Minutes Post Stimulation. | .617 ± .608 | .710 ± .661 |
Effort is how difficult is was for a subject to use a specific emotion regulation technique. Subjects will be asked to rate how much effort they felt they used on a 7 point Likert scale ranging from 1 (very little effort) to 7 (very high effort) after using an emotion regulation technique (distraction) when shown graphic stimuli.
| score on a scale | Transcranial Magnetic Stimulation (TMS) | Sham TMS |
|---|---|---|
| Change in Self-reported Effort (Distraction) From Baseline to 30 Minutes Post Stimulation. | 3.620 ± 1.083 | 3.590 ± 1.146 |
Collected over 30 minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Sham TMS | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
All subjects who completed the study protocol.
| Age, Categorical(Participants) | Transcranial Magnetic Stimulation (TMS), Then Sham TMS | Sham TMS, Then Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 15 | 30 |
| >=65 years | 0 | 0 | 0 |
| Sex/Gender, Customized(Participants) | Transcranial Magnetic Stimulation (TMS), Then Sham TMS | Sham TMS, Then Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| Female | 12 | 8 | 20 |
| Male | 3 | 7 | 10 |
| Unknown/unlisted | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Transcranial Magnetic Stimulation (TMS), Then Sham TMS | Sham TMS, Then Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 11 | 8 | 19 |
| Unknown or Not Reported | 3 | 6 | 9 |
| Race (NIH/OMB)(Participants) | Transcranial Magnetic Stimulation (TMS), Then Sham TMS | Sham TMS, Then Transcranial Magnetic Stimulation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 8 | 16 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Plan to share: No — De-identified data relating to the primary and secondary outcomes will be uploaded upon completion of the study.
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