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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04650438
Other study ID # 2018-01578
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 2021
Est. completion date February 2022

Study information

Verified date November 2023
Source Insel Gruppe AG, University Hospital Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 2022
Est. primary completion date February 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Creativity Performance in Healthy Subjects

Intervention

Device:
Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG)
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.
Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in creativity performance prior- and post-TMS 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 Change in creativity performance prior- and post-TMS depending on stimulation location 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