Healthy AgingNCT04361760
Signal Propagation and Its Relationship to Cognitive Performance in the Aging Human Brain (Focus or Spread)
A study testing single-puls TMS in people with Healthy Aging, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- single-puls TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jun 2020to 18 May 2021
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, Inselspital, Bern University Hospital
Bern, 3010
About this study
Official title: Better to Focus or to Spread? Signal Propagation and Its Relationship to Cognitive Performance in the Aging Human Brain
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.
- Conditions
- Healthy Aging
- Being tested
- single-puls TMS, sham stimulation
- Keywords
- transcranial magnetic stimulation (TMS), high-density electroencephalography (hd-EEG), simultaneous TMS-hd-EEG, diffusion tensor imaging (DTI), neural dedifferentiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single-puls TMSDevice
Medical Device (MD): MagPro X100
sham stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy younger participants (20-30y) | Experimental | 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. Receives: Device: single-puls TMS; Device: sham stimulation |
| Healthy older participants (65-75y) | Experimental | 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. Receives: Device: single-puls TMS; Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (3)
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.
Measured: 4 hours
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.
Measured: 4 hours
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start25 Jun 2020
- Primary completion8 Apr 2021
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361760
- Sponsor's protocol ID
- 2020-00258
- Status last verified
- Oct 2021
- First submitted
- 22 Apr 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 14735112Raz 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.
PubMed 16919333Park 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.
PubMed 22323727Sala-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.
PubMed 26052298Ziemann 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.
PubMed 21311054Ozdemir 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.
PubMed 32193345
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better to Focus or to Spread? Signal Propagation and Its Relationship to Cognitive Performance in the Aging Human Brain
- ClinicalTrials.gov ID
- NCT04361760
- Acronym / sponsor ID
- 2020-00258
- Conditions
- Healthy Aging
- Keywords
- transcranial magnetic stimulation (TMS), high-density electroencephalography (hd-EEG), simultaneous TMS-hd-EEG, diffusion tensor imaging (DTI), neural dedifferentiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 24 Apr 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy younger participants (20-30y) | Experimental | Device: single-puls TMS, Device: sham stimulationWithin-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. |
| Healthy older participants (65-75y) | Experimental | Device: single-puls TMS, Device: sham stimulationWithin-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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| single-puls TMSMedical Device (MD): MagPro X100 | Device | Healthy older participants (65-75y), Healthy younger participants (20-30y) |
| sham stimulationSham 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. | Device | Healthy older participants (65-75y), Healthy younger participants (20-30y) |
Primary outcome
Age-related differences in the spatio-temporal patterns of signal propagation
Time frame: 2 hours
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.
3 secondary outcomes
Association between the performance in a cognitive test battery and patterns of signal propagation in younger and older participants
Time frame: 4 hours
Association between the performance in a cognitive test battery and patterns of signal propagation in better- and worse-performers
Time frame: 4 hours
Association between the patterns of signal propagation and the structural properties of the white matter
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Background: PubMed 14735112Hedden 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.
- Background: PubMed 16919333Raz 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.
- Background: PubMed 22323727Park 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.
- Background: PubMed 26052298Sala-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.
- Background: PubMed 21311054Ziemann 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.
- Background: PubMed 32193345Ozdemir 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.
- Individual participant dataSharing planned: Yes
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single-puls TMS in people with Healthy Aging, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 17 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: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Age-related differences in the spatio-temporal patterns of signal propagation (time frame: 2 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 NCT04361760, which also lists 6 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 5 Oct 2021.