Clinical trial NCT03698591: Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.
Official title: Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Real Versus Sham Transcranial Magnetic Stimulation (TMS)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18-39 years inclusive
* Willing to provide informed consent
* English speaking
* Signed HIPAA authorization

Exclusion Criteria:

* Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (assessed via urine test).
* Current serious medical illness (assessed via self report).
* History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator) \[assessed via TMS Adult Safety Screening form\].
* Subjects are unable or unwilling to give informed consent.
* Diagnosed any Axis I Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) disorder (assessed via self report).
* Subjects with a clinically defined neurological disorder (assessed via self report) including, but not limited to:

  1. Any condition likely to be associated with increased intracranial pressure
  2. Space occupying brain lesion.
  3. History of stroke.
  4. Transient ischemic attack within two years.
  5. Cerebral aneurysm.
  6. Dementia.
  7. Parkinson's disease.
  8. Huntington's disease.
  9. Multiple sclerosis.
* Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold (assess via self report).
* Subjects not willing to tolerate the confinement associated with being in the MRI scanner.
* Women who are pregnant or breast-feeding (assessed via urine test).
* Blindness.
* Inability to read or understand English.
* Intracranial implants, such as:

  1. Cochlear implants;
  2. Aneurysms clips;
  3. Shunts;
  4. Stimulators;
  5. Electrodes;
  6. Cardiac pacemakers;
  7. Vagus Nerve stimulation devices.

Primary outcomes:
measure: Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.
timeFrame: baseline, 30 minutes post stimulation
Secondary outcomes:
measure: Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation.
timeFrame: baseline, 30 minutes post stimulation
Other outcomes:
measure: Change in Self-reported Valence (Distraction) From Baseline to 30 Minutes Post Stimulation.
timeFrame: baseline, 30 minutes post stimulation
measure: Change in Self-reported Effort (Distraction) From Baseline to 30 Minutes Post Stimulation.
timeFrame: baseline, 30 minutes post stimulation
Locations:
city: Durham
country: United States
facility: LaBar Lab, Duke University
state: North Carolina
Study officials:
affiliation: Duke University Faculty
name: Kevin S LaBar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorfel D, Lamke JP, Hummel F, Wagner U, Erk S, Walter H. Common and differential neural networks of emotion regulation by Detachment, Reinterpretation, Distraction, and Expressive Suppression: a comparative fMRI investigation. Neuroimage. 2014 Nov 1;101:298-309. doi: 10.1016/j.neuroimage.2014.06.051. Epub 2014 Jun 30.
citation: Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
citation: Madore KP, Thakral PP, Beaty RE, Addis DR, Schacter DL. Neural Mechanisms of Episodic Retrieval Support Divergent Creative Thinking. Cereb Cortex. 2019 Jan 1;29(1):150-166. doi: 10.1093/cercor/bhx312.
citation: McRae K, Hughes B, Chopra S, Gabrieli JD, Gross JJ, Ochsner KN. The neural bases of distraction and reappraisal. J Cogn Neurosci. 2010 Feb;22(2):248-62. doi: 10.1162/jocn.2009.21243.
citation: Winecoff A, Labar KS, Madden DJ, Cabeza R, Huettel SA. Cognitive and neural contributors to emotion regulation in aging. Soc Cogn Affect Neurosci. 2011 Apr;6(2):165-76. doi: 10.1093/scan/nsq030. Epub 2010 Apr 12.
citation: Powers JP, Davis SW, Neacsiu AD, Beynel L, Appelbaum LG, LaBar KS. Examining the Role of Lateral Parietal Cortex in Emotional Distancing Using TMS. Cogn Affect Behav Neurosci. 2020 Oct;20(5):1090-1102. doi: 10.3758/s13415-020-00821-5.