Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

Emotion Regulation Clinical Trial

Official title:

Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03698591
• Other study ID #: Pro00100171
• Status: Completed
• Phase: N/A
• Start date: October 31, 2018
• Est. completion date: May 24, 2019

Study information

• Verified date: December 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotion Regulation
• Real Versus Sham Transcranial Magnetic Stimulation (TMS)

Intervention

Device:
• 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.
• Sham transcranial magnetic stimulation task
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.

Locations

Country	Name	City	State
United States	LaBar Lab, Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Dörfel 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	baseline, 30 minutes post stimulation
Other	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.	baseline, 30 minutes post stimulation
Primary	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.	baseline, 30 minutes post stimulation
Secondary	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.	baseline, 30 minutes post stimulation