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Emotion RegulationNCT03698591

Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.

A study testing Transcranial magnetic stimulation task in people with Emotion Regulation and Real Versus Sham Transcranial Magnetic Stimulation (TMS), run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
What is being tested?
Transcranial magnetic stimulation task
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
31 Oct 2018to 24 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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:
Show all 28Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LaBar Lab, Duke University

    Durham, North Carolina, 27708

Other trials in United States

About this study

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.

Read the 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.

Being tested
Transcranial magnetic stimulation task, Sham transcranial magnetic stimulation task
Medical subject headings
Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial magnetic stimulation taskDevice

    Also called TMS

    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 taskDevice

    Also called Sham 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.

Study groups in NCT03698591
Study groupRoleWhat they receive
Transcranial magnetic stimulation (TMS), then Sham TMS.ExperimentalExperimenters 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.
Receives: Device: Transcranial magnetic stimulation task
Sham TMS, then Transcranial magnetic stimulation (TMS)Sham comparatorExperimenters 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.
Receives: Device: Sham transcranial magnetic stimulation task

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 30 minutes post stimulation

Secondary outcomes (1)

  1. 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.

    Measured: baseline, 30 minutes post stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start31 Oct 2018
  3. Primary completion24 May 2019
  4. Study completion24 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698591
Sponsor's protocol ID
Pro00100171
Status last verified
Dec 2019
First submitted
4 Oct 2018
Last updated
17 Dec 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: De-identified data relating to the primary and secondary outcomes will be uploaded upon completion of the study.

Publications

  • 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.

    PubMed 24993897

  • 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.

    PubMed 15664172

  • 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.

    PubMed 29161358

  • 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.

    PubMed 19400679

  • 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.

    PubMed 20385663

  • 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.

    PubMed 32839957

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial magnetic stimulation task in people with Emotion Regulation and Real Versus Sham Transcranial Magnetic Stimulation (TMS), run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation. (time frame: baseline, 30 minutes post stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03698591, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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