Creativity Performance in Healthy SubjectsNCT04650438
Sleep and Creativity
A study testing Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG) and Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL) in people with Creativity Performance in Healthy Subjects, run by Insel Gruppe AG, University Hospital Bern.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Creativity Performance in Healthy Subjects
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG) and Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
- Being tested
- Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG), Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| High-creativity | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG); Device: Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL) |
| Low-creativity | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG); Device: Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2.5 hours
Secondary outcomes (1)
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)
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study startApr 2021 (estimated)
- Primary completionFeb 2022 (estimated)
- Study completionFeb 2022 (estimated)
Why it stopped: The study did not start due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Creativity Performance in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Single-blind, randomized, cross-over trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René M. Müri, Prof. Dr., Principal investigator, Department of Neurology Inselspital, Bern University HospitalClaudio Bassetti, Prof. Dr., Study chair, Department of Neurology Inselspital, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650438
- Sponsor's protocol ID
- 2018-01578
- Other IDs
- 2018
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2020
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 25245940Jung 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.
PubMed 26508284Lustenberger 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.
PubMed 25913062Nyffeler 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.
PubMed 16462596Rossi 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.
PubMed 19833552Park 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.
PubMed 25979607Vartanian 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.
PubMed 29477840
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Creativity
- ClinicalTrials.gov ID
- NCT04650438
- Acronym / sponsor ID
- 2018-01578
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start due to COVID-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, randomized, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| High-creativity | Experimental | Device: Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG), Device: Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)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. |
| Low-creativity | Experimental | Device: Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG), Device: Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | High-creativity, Low-creativity |
| 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. | Device | High-creativity, Low-creativity |
Primary outcome
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
1 secondary outcome
Change in creativity performance prior- and post-TMS depending on stimulation location
Time frame: 2.5 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Background: PubMed 25245940Beaty 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.
- Background: PubMed 26508284Jung 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.
- Background: PubMed 25913062Lustenberger 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.
- Background: PubMed 16462596Nyffeler 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.
- Background: PubMed 19833552Rossi 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.
- Background: PubMed 25979607Park 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.
- Background: PubMed 29477840Vartanian 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René M. Müri, Prof. Dr. principal investigator
Department of Neurology Inselspital, Bern University Hospital
Claudio Bassetti, Prof. Dr. study chair
Department of Neurology Inselspital, Bern University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG) and Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL) in people with Creativity Performance in Healthy Subjects, run by Insel Gruppe AG, University Hospital Bern.
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 8 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: withdrawn, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 creativity performance prior- and post-TMS (time frame: 2.5 hours). 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 NCT04650438, which also lists 7 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 7 Dec 2023.