N/A
N=40
Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.
Emotion Regulation · Real Versus Sham Transcranial Magnetic Stimulation (TMS)
Bottom Line
View on ClinicalTrials.gov: NCT03698591 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation. — .662; .668 score on a scale — p=.019
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial magnetic stimulation task (Device); Sham transcranial magnetic stimulation task (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-reported Valence (Distancing) From Baseline to 30 Minutes Post Stimulation. |
.662; .668 | .019 sig |
| SECONDARY Change in Self-reported Effort (Distancing) From Baseline to 30 Minutes Post Stimulation. |
3.610; 3.546 | .862 |
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.
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT03698591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.