Skip to main content
OpenTrials
Completed

NCT Number: NCT03698591

Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LaBar Lab, Duke University

Durham, North Carolina, 27708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Any condition likely to be associated with increased intracranial pressure
  • Space occupying brain lesion.
  • History of stroke.
  • Transient ischemic attack within two years.
  • Cerebral aneurysm.
  • Dementia.
  • Parkinson's disease.
  • Huntington's disease.
  • 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:
  • Cochlear implants;
  • Aneurysms clips;
  • Shunts;
  • Stimulators;
  • Electrodes;
  • Cardiac pacemakers;
  • Vagus Nerve stimulation devices.

Treatment and study plan

Transcranial magnetic stimulation task

Device

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.

Other names: TMS

Sham transcranial magnetic stimulation task

Device

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.

Other names: Sham TMS

Primary outcomes

  1. Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation.

    Time frame: baseline, 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.

Secondary outcomes

  1. Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation.

    Time frame: baseline, 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.

Other outcomes

  1. Change in Self-reported Valence (Distraction) From Baseline to 30 Minutes Post Stimulation.

    Time frame: baseline, 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.

  2. Change in Self-reported Effort (Distraction) From Baseline to 30 Minutes Post Stimulation.

    Time frame: baseline, 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.