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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04361760
Other study ID # 2020-00258
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2020
Est. completion date May 18, 2021

Study information

Verified date October 2021
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In the next three decades, the world's population over 60 years old is expected to more than double its size. Even in the absence of an obvious pathology (i.e., healthy aging), advancing age is typically associated with a progressive decline in cognitive performance. Although pathophysiological changes in age-related neurodegenerative disorders have received much attention over the past years, far less is known about the neural processes affecting cognition in healthy ageing. One of these postulated processes is neural dedifferentiation (i.e., a decrease in neural selectivity, by which neural representations of processed information become less univocally distinguishable), possibly accompanied by the recruitment of additional cortical areas in the healthy aging brain. To date, these processes have been extensively studied on the neural level, yet their functional significance for cognitive behaviour remains largely unclear. This project will investigate neural dedifferentiation and its relationship to cognitive performance in the healthy aging brain. To this end, the investigators will use a combination of state-of-the-art technologies including simultaneous transcranial magnetic stimulation (TMS) and high-density electroencephalography (hd-EEG) as well as diffusion tensor imaging (DTI). Perspectives include a better understanding of the relationship between neurophysiological mechanisms and cognitive performance in the healthy aging brain.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 18, 2021
Est. primary completion date April 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 75 Years
Eligibility Inclusion Criteria: - Informed consent as documented by signature - Age between 20-30 or 65-75 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 present, including seizures or febrile convulsions) - Any surgical intervention to the brain - Heart diseases - Implanted medical devices (e.g., cochlear implants, infusion pumps, neurostimulators, pacemakers) - History of migraine or strong headaches - Sleep deprivation - Presence of non-MRI safe metal in the body - Drug or alcohol abuse - Intake of any medication that is likely to lower seizure threshold - Claustrophobia - For female participants: in order to participate in the study, female participants in reproductive age need to take a pregnancy test (a standard urine pregnancy test will be provided). - For female participants: breastfeeding - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, etc. of the participant - Lack of knowledge of the German language - Participation in another study with investigational drug within the 30 days preceding and during the present study - Previous enrolment into the current study - Enrolment of the investigator, his/her family members, employees and other dependent persons

Study Design


Related Conditions & MeSH terms


Intervention

Device:
single-puls TMS
Medical Device (MD): MagPro X100
sham stimulation
Sham stimulation is delivered with a dedicated coil, which is magnetically shielded and thus produces only approx. 20% of the nominal magnetic field. This is not enough to reach and stimulate the cortex, but the produced sound and scalp sensation are the same as with a real TMS coil.

Locations

Country Name City State
Switzerland Department of Neurology, Inselspital, Bern University Hospital Berne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

Hedden T, Gabrieli JD. Insights into the ageing mind: a view from cognitive neuroscience. Nat Rev Neurosci. 2004 Feb;5(2):87-96. Review. — View Citation

Ozdemir RA, Tadayon E, Boucher P, Momi D, Karakhanyan KA, Fox MD, Halko MA, Pascual-Leone A, Shafi MM, Santarnecchi E. Individualized perturbation of the human connectome reveals reproducible biomarkers of network dynamics relevant to cognition. Proc Natl Acad Sci U S A. 2020 Apr 7;117(14):8115-8125. doi: 10.1073/pnas.1911240117. Epub 2020 Mar 19. — View Citation

Park J, Carp J, Kennedy KM, Rodrigue KM, Bischof GN, Huang CM, Rieck JR, Polk TA, Park DC. Neural broadening or neural attenuation? Investigating age-related dedifferentiation in the face network in a large lifespan sample. J Neurosci. 2012 Feb 8;32(6):2154-8. doi: 10.1523/JNEUROSCI.4494-11.2012. — View Citation

Raz N, Rodrigue KM. Differential aging of the brain: patterns, cognitive correlates and modifiers. Neurosci Biobehav Rev. 2006;30(6):730-48. Epub 2006 Aug 17. Review. — View Citation

Sala-Llonch R, Bartrés-Faz D, Junqué C. Reorganization of brain networks in aging: a review of functional connectivity studies. Front Psychol. 2015 May 21;6:663. doi: 10.3389/fpsyg.2015.00663. eCollection 2015. Review. — View Citation

Ziemann U. Transcranial magnetic stimulation at the interface with other techniques: a powerful tool for studying the human cortex. Neuroscientist. 2011 Aug;17(4):368-81. doi: 10.1177/1073858410390225. Epub 2011 Feb 10. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Age-related differences in the spatio-temporal patterns of signal propagation The spatiotemporal patterns of signal propagation, as measured with a combined TMS-hd-EEG approach, in younger and older healthy participants, reflecting age-related differences on the neural level. 2 hours
Secondary Association between the performance in a cognitive test battery and patterns of signal propagation in younger and older participants The association between the performance in a specific cognitive test and the aforementioned patterns of signal propagation in younger and older healthy participants, reflecting the functional significance of these age-related patterns on the cognitive level. 4 hours
Secondary Association between the performance in a cognitive test battery and patterns of signal propagation in better- and worse-performers The association between the performance in a specific cognitive test and the aforementioned patterns of signal propagation in better- and worse-performers, reflecting the functional significance of these age-independent patterns on the cognitive level. 4 hours
Secondary Association between the patterns of signal propagation and the structural properties of the white matter The association between the aforementioned patterns of signal propagation and the structural properties of the white matter interconnecting the involved cortical areas, as measured by DTI. 4 hours
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