Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

NCT03698591 | Completed Results DMC FDA Device

• 1 other identifier: Pro00100171
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  baseline, 30 minutes post stimulation

Other Outcomes (2)

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

  baseline, 30 minutes post stimulation

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

  baseline, 30 minutes post stimulation

Study Arms (2)

Transcranial magnetic stimulation (TMS), then Sham TMS.

EXPERIMENTAL

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

Sham TMS, then Transcranial magnetic stimulation (TMS)

SHAM COMPARATOR

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

Interventions

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.

Also known as: TMS

Transcranial magnetic stimulation (TMS), then Sham 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.

Also known as: Sham TMS

Sham TMS, then Transcranial magnetic stimulation (TMS)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

LaBar Lab, Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (6)

• 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.

  PMID: 24993897 BACKGROUND

• 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.

  PMID: 15664172 BACKGROUND

• 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.

  PMID: 29161358 BACKGROUND

• 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.

  PMID: 19400679 BACKGROUND

• 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.

  PMID: 20385663 BACKGROUND

• 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.

  PMID: 32839957 DERIVED

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Results Point of Contact

• Title: Dr. Kevin LaBar, PhD.
• Organization: Duke University

klabar@duke.edu

(919)668-2424

Study Officials

• Kevin S LaBar, PhD

  Duke University Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the lead experimenter nor the subject will know which arm they will complete first. The secondary experimenter will use a randomized counter-balanced log to determine the order of sequences will take place. The secondary experimenter will set up the device while the lead experimenter is out of the room to preserve blindness to the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: October 31, 2018
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: December 17, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)