Signal Propagation and Its Relationship to Cognitive Performance in the Aging Human Brain (Focus or Spread)

NCT ID: NCT04361760

Last Updated: 2021-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2021-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Aging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy younger participants (20-30y)

Within-subject design. In a visual discrimination task participants will be asked to identify specific features of visual stimuli (i.e., the gender of a face, or the motion direction of a grating). During this task, single-pulse TMS will be applied in one-third of the trials; sham stimulation will be applied in a further third of the trials; and no stimulation will be applied in the remaining third of the trials, while hd-EEG will be continuously measured. The order of these three stimulation conditions (i.e., single-pulse TMS, sham, or no stimulation, during the 1st, 2nd, or 3rd third of the trials) will be counterbalanced over participants.

Group Type EXPERIMENTAL

single-puls TMS

Intervention Type DEVICE

Medical Device (MD): MagPro X100

sham stimulation

Intervention Type DEVICE

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.

Healthy older participants (65-75y)

Within-subject design. In a visual discrimination task participants will be asked to identify specific features of visual stimuli (i.e., the gender of a face, or the motion direction of a grating). During this task, single-pulse TMS will be applied in one-third of the trials; sham stimulation will be applied in a further third of the trials; and no stimulation will be applied in the remaining third of the trials, while hd-EEG will be continuously measured. The order of these three stimulation conditions (i.e., single-pulse TMS, sham, or no stimulation, during the 1st, 2nd, or 3rd third of the trials) will be counterbalanced over participants.

Group Type EXPERIMENTAL

single-puls TMS

Intervention Type DEVICE

Medical Device (MD): MagPro X100

sham stimulation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

single-puls TMS

Medical Device (MD): MagPro X100

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

René M. Müri, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Inselspital, Bern University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Neurology, Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Hedden T, Gabrieli JD. Insights into the ageing mind: a view from cognitive neuroscience. Nat Rev Neurosci. 2004 Feb;5(2):87-96. doi: 10.1038/nrn1323. No abstract available.

Reference Type BACKGROUND
PMID: 14735112 (View on PubMed)

Raz N, Rodrigue KM. Differential aging of the brain: patterns, cognitive correlates and modifiers. Neurosci Biobehav Rev. 2006;30(6):730-48. doi: 10.1016/j.neubiorev.2006.07.001. Epub 2006 Aug 17.

Reference Type BACKGROUND
PMID: 16919333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22323727 (View on PubMed)

Sala-Llonch R, Bartres-Faz D, Junque 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.

Reference Type BACKGROUND
PMID: 26052298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21311054 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32193345 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-00258

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Restructuring the Alpha-Gamma Code in Aging Vision
NCT07208318 NOT_YET_RECRUITING EARLY_PHASE1
Neural Bases of Motivation
NCT07251816 RECRUITING NA
Multifocal HD-tDCS and Motor Function
NCT06561165 RECRUITING NA