- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04650438
Sleep and Creativity
Creativity is a complex neuro-psycho-philosophical phenomenon that is difficult to define. Neurocognitive models of creativity suggest that creativity is associated with the activity of a distributed, bilateral fronto-temporal and parietal network. Therefore, a modulation of frontal activity is necessary to allow a certain degree of "controlled disinhibition", which seems to be necessary for creative thinking. In addition, a modulation of the lower parietal lobe (IPL) might allow targeting the brain regions responsible for idea generation.
This project will investigate the application of transcranial magnetic stimulation (TMS) with the intent of modulating creativity performance of healthy subjects. Resting state electroencephalography (EEG) that will be acquired pre- and post-TMS and participants' creative performance will be measured.
Perspectives include a better understanding of the differences between high- and low-creativity groups, as measured by a creativity test battery, in their response to TMS. Additional perspectives are whether there are differences in creativity performance depending on the stimulation location.
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Berne, Switzerland, 3010
- Department of Neurology Inselspital, Bern University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Informed consent as documented by signature
- Age between 18 and 70 years
- Neurologically healthy, i.e., with no documented or present neurological disease or brain injury
- Normal or corrected-to-normal visual acuity
Exclusion Criteria:
- Any instable medical condition, in particular epilepsy (past or pre-sent, including seizures or febrile convulsions)
- Any surgical intervention to the brain
- Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers)
- Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
- Drug or alcohol abuse
- Intake of any medication that is likely to lower seizure threshold
- For female participants: in order to participate in the study, female patients in reproductive age need to take a pregnancy test (a stand-ard urine pregnancy test will be provided).
- Previous enrolment in a creativity study of the same PI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High-creativity
Here participants are allocated to the high-creativity group.
Resting state EEG will be measured pre- and post-TMS and participants' creative performance will be measured by means of a creativity test battery.
|
MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125).
The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice.
Continuous theta burst stimulation protocol will be applied.
MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125).
The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice.
Continuous theta burst stimulation protocol will be applied.
|
|
Experimental: Low-creativity
Here participants are allocated to the low-creativity group.
Resting state EEG will be measured pre- and post-TMS and participants' creative performance will be measured by means of a creativity test battery.
|
MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125).
The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice.
Continuous theta burst stimulation protocol will be applied.
MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125).
The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice.
Continuous theta burst stimulation protocol will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in creativity performance prior- and post-TMS
Time Frame: 2.5 hours
|
Change in creativity performance (as expressed by a summary score of single tests from a creativity test battery) prior- and post-TMS in low- and high-creativity groups
|
2.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in creativity performance prior- and post-TMS depending on stimulation location
Time Frame: 2.5 hours
|
Change in creativity performance (as expressed by a summary score of single tests from a creativity test battery) prior- and post-TMS depending on the stimulation location (left IFG versus left IPL)
|
2.5 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: René M. Müri, Prof. Dr., Department of Neurology Inselspital, Bern University Hospital
- Study Chair: Claudio Bassetti, Prof. Dr., Department of Neurology Inselspital, Bern University Hospital
Publications and helpful links
General Publications
- Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Vartanian O, Beatty EL, Smith I, Blackler K, Lam Q, Forbes S. One-way traffic: The inferior frontal gyrus controls brain activation in the middle temporal gyrus and inferior parietal lobule during divergent thinking. Neuropsychologia. 2018 Sep;118(Pt A):68-78. doi: 10.1016/j.neuropsychologia.2018.02.024. Epub 2018 Feb 23.
- Beaty RE, Benedek M, Wilkins RW, Jauk E, Fink A, Silvia PJ, Hodges DA, Koschutnig K, Neubauer AC. Creativity and the default network: A functional connectivity analysis of the creative brain at rest. Neuropsychologia. 2014 Nov;64:92-8. doi: 10.1016/j.neuropsychologia.2014.09.019. Epub 2014 Sep 20.
- Jung J, Bungert A, Bowtell R, Jackson SR. Vertex Stimulation as a Control Site for Transcranial Magnetic Stimulation: A Concurrent TMS/fMRI Study. Brain Stimul. 2016 Jan-Feb;9(1):58-64. doi: 10.1016/j.brs.2015.09.008. Epub 2015 Sep 25.
- Lustenberger C, Boyle MR, Foulser AA, Mellin JM, Frohlich F. Functional role of frontal alpha oscillations in creativity. Cortex. 2015 Jun;67:74-82. doi: 10.1016/j.cortex.2015.03.012. Epub 2015 Apr 1.
- Nyffeler T, Wurtz P, Pflugshaupt T, von Wartburg R, Luthi M, Hess CW, Muri RM. One-Hertz transcranial magnetic stimulation over the frontal eye field induces lasting inhibition of saccade triggering. Neuroreport. 2006 Feb 27;17(3):273-5. doi: 10.1097/01.wnr.0000199468.39659.bf.
- Park HR, Kirk IJ, Waldie KE. Neural correlates of creative thinking and schizotypy. Neuropsychologia. 2015 Jul;73:94-107. doi: 10.1016/j.neuropsychologia.2015.05.007. Epub 2015 May 12.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-01578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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