Mild Cognitive ImpairmentNiBS-iCogNCT04986787
Novel, Individualized Brain Stimulation, Network-based Approaches to Improve Cognition
A study testing tACS, TMS and TIS in people with Mild Cognitive Impairment and Healthy Aging, run by Masaryk University at 1 site in Czechia.
Trial summary
Impaired working memory (WM) plays a crucial role in normal aging, in mild cognitive impairment (MCI) and cognitive decline associated with dementia, such as Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Aging
- What is being tested?
- tACS, TMS and TIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2021to 31 Dec 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal cognitive performance as assessed by a cognitive screening for healthy subjects
- mild cognitive impairment as assessed by detailed cognitive testing ± positive AD diagnostic biomarkers for MCI subjects
Who cannot join
- Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
Trial locations and contacts
1 site in 1 country.
Traian Popa contact
Czechia1 site, 1 recruiting
- Recruiting
Ceitec Masaryk University
Brno, 62500
Lubomira Anderkova, PhD, +420 549 497 766
About this study
Official title: Novel, Individualized Brain Stimulation, Network-based Approaches to Improve Cognition in Healthy Seniors and Patients With MCI
Impaired working memory (WM) plays a crucial role in normal aging, in mild cognitive impairment (MCI) and cognitive decline associated with dementia, such as Alzheimer's disease (AD). The aging-related differences in WM are hypothesized to be based on various neurobiological origins, for example alterations in the dynamic interplay between the large-scale brain networks have proven an important role. Recent studies have shown that non-invasive brain stimulation (NIBS) methods can modulate neuronal activity, plasticity and large-scale brain network interactions. The investigators hypothesize that multifocal NIBS can improve WM. By successive and concurrent stimulation of multiple brain regions of the WM network by transcranial alternating current stimulation (tACS) and/or repetitive transcranial magnetic stimulation (rTMS) the investigators will study dynamic interactions between distinct cortico-cortical and subcortico-cortical brain areas. By leveraging multimodal systems neuroscience information during multifocal stimulation, the investigators expect to acquire better mechanistic understand through which NIBS acts on the brain and improves cognitive functions, such as WM.
Read the detailed description
Mild cognitive impairment (MCI) describes an intermediate stage from normal cognitive functioning to dementia, and identifies a spectrum of diseases that includes impairment in both memory and non-memory cognitive domains. A deficient working memory (WM) plays a crucial role in normal aging, MCI, and cognitive decline associated with dementia, such as Alzheimer's disease (AD). WM refers to the on-line temporary storage and manipulation of information to be employed in ongoing processing, and is central to the execution of a variety of daily functions. The loss of WM efficiency related to either aging or neurodegenerative process is hypothesized to have various neurobiological roots, among which altered functioning of the fronto-parietal networks play an important role. The processing, exchange, and storing of information rely on intra- and interregional connectivity that allow neuronal populations to synchronize their firing. Based on this, intra- and cross frequency oscillatory interactions have been demonstrated as core basis for working memory processes, besides other cognitive functions. Any impairment preventing the adaptation and synchronization of the oscillatory activities within this network will inevitably lead to temporary or permanent loss of function.
In this project, based on the mentioned pathophysiological concepts, the investigators will develop and test novel, individualized, multifocal, physiology-inspired non-invasive brain stimulation (NIBS) approaches aimed at enhancing interregional processing in memory-related fronto-parieto-cerebello networks with consecutive behavioral modulation of WM processes impacting on daily life activities in aged healthy volunteers (HV) and MCI patients.
The investigators approach these aims in a step-wise manner: (1) The investigators will explore entrainment of oscillatory activity in the fronto-parietal network with transcranial alternative current stimulation (tACS) at frequencies relevant to memory encoding (theta) to boost WM in healthy seniors. (2) Then, the investigators will explore cross-frequency entrainment of interregional oscillatory interactions in the frontal and parietal target network with bifocal tACS to boost WM in healthy seniors. (3) Based on the current knowledge about the extensive involvement of the cerebellum in cognitive processes by its modulatory effects onto the fronto-parietal networks crucial for cognition, the investigators will leverage our experience in non-invasive modulation of the cerebellar outputs by means of repetitive transcranial magnetic stimulation (rTMS). rTMS over the cerebellum will be applied just before cortical entrainment to further enhance its physiological and behavioral effects. (4) Finally, the investigators will select the most effective approach from the previous work-packages to be applied in MCI patients and quantify the behavioral benefits. Besides the behavioral effects, the investigators will apply multimodal systems neuroscience approaches by means of neuroimaging (structural and functional magnetic resonance imaging; s/fMRI) and electrophysiological (Electroencephalography - EEG, transcranial magnetic stimulation - TMS) methods to determine the underlying network mechanisms and patterns of intrinsic connectivity changes. As there is significant spatial heterogeneity in fronto-parietal peak activity in healthy seniors and patients, stimulation targets will be individually defined based on fMRI. By leveraging the mechanistic aspects derived from individualized multifocal stimulation, the investigators expect to better understand the mechanisms through which NIBS techniques act on the brain and improve cognitive functions. The investigators will also test and quantify within a virtual reality (VR) task how well the intervention-driven cognitive improvement translates into daily life.
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Being tested
- tACS, TMS, TIS
- Keywords
- non-invasive brain stimulation, tACS, TMS, cognition, working memory, MCI, healthy ageing, EEG, neuroimaging (MRI), oscillatory activity
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
a non-invasive brain stimulation technique that allows interaction with endogenous cortical oscillatory rhythms
TMSDevice
a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain, it will be specifically cerebellar stimulation
TISDevice
temporal interference stimulation targeted to striatum, a non-invasive brain stimulation technique that allows interaction with endogenous cortical oscillatory rhythms deep in the brain
| Study group | Role | What they receive |
|---|---|---|
| Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - within-frequency | Experimental | double-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized fronto-parietal tACS on a visual working memory task in aged HV Receives: Device: tACS |
| Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - cross-frequency | Experimental | double-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized cross-frequency fronto-parietal tACS stimulation on a visual WM task in aged HV Receives: Device: tACS |
| Cerebellar rTMS to modify the effects of cortico-cortical, fronto-parietal tACS in HV | Experimental | double-blind, randomized, sham-controlled, cross-over trial assessing the effects of cerebellar stimulation on individualized fronto-parietal tACS stimulation during a visual WM task in aged HV Receives: Device: tACS; Device: TMS |
| Neuromodulation protocol in MCI patients (precise protocol to be chosen on results of previous arms) | Experimental | double-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized striatal TIS combined with cereberal TMS on a visual working memory task in MCI patients Receives: Device: TMS; Device: TIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory performance
We will compare the baseline-normalized reaction time and error rate of a N-back task between the real and sham stimulation condition in a cross-over design.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
The reproducibility of the outcomes of this proof-of-concept brain stimulation in MCI between centers
Twenty MCI patients will be recruited in each participating center. The reproducibility of the effects induced by the intervention will be assessed by comparing the baseline-normalized error rate of a N-back task between the two centers.
Measured: through study completion, an average of 1 year
The neural underpinning of NIBS-induced changes quantified by s/fMRI and network-based analytical approaches.
The changes in intra- and inter-regional fMRI connectivity within and between cognitive brain networks will be compared between the real and sham stimulations.
Measured: The changes will be computed from the difference between connectivity at baseline and 1 hour post-stimulation.
The neural underpinning of NIBS-induced changes quantified by EEG.
We will measure cortical excitability by TMS-EEG pairing via TMS-evoked potentials.
Measured: Baseline and 1 hour after the delivery of real or sham intervention - cross-over design.
Transfer of the acquired WM abilities during the intervention into a daily-life relevant scenario as assessed by The Virtual Supermarket Shopping Task.
The accuracy of the post-stimulation WM task in a VR-based daily life scenario as assessed by The Virtual Supermarket Shopping Task will be compared between the real or sham intervention (cross-over design).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Friedhelm C. Hummel, Principal investigator, Ecole Polytechnique Fédérale de LausanneIrena Rektorova, Principal investigator, CEITEC Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986787
- Sponsor's protocol ID
- GF21-13462L
- Acronym
- NiBS-iCog
- Status last verified
- May 2023
- First submitted
- 19 Apr 2021
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared only within both centres
Publications
Saunders NL, Summers MJ. Attention and working memory deficits in mild cognitive impairment. J Clin Exp Neuropsychol. 2010 Apr;32(4):350-7. doi: 10.1080/13803390903042379. Epub 2009 Sep 25.
PubMed 19787522Johnson EL, Dewar CD, Solbakk AK, Endestad T, Meling TR, Knight RT. Bidirectional Frontoparietal Oscillatory Systems Support Working Memory. Curr Biol. 2017 Jun 19;27(12):1829-1835.e4. doi: 10.1016/j.cub.2017.05.046. Epub 2017 Jun 9.
PubMed 28602658Roux F, Uhlhaas PJ. Working memory and neural oscillations: alpha-gamma versus theta-gamma codes for distinct WM information? Trends Cogn Sci. 2014 Jan;18(1):16-25. doi: 10.1016/j.tics.2013.10.010. Epub 2013 Nov 19.
PubMed 24268290Kornblith S, Buschman TJ, Miller EK. Stimulus Load and Oscillatory Activity in Higher Cortex. Cereb Cortex. 2016 Sep;26(9):3772-84. doi: 10.1093/cercor/bhv182. Epub 2015 Aug 18.
PubMed 26286916Eldaief MC, Halko MA, Buckner RL, Pascual-Leone A. Transcranial magnetic stimulation modulates the brain's intrinsic activity in a frequency-dependent manner. Proc Natl Acad Sci U S A. 2011 Dec 27;108(52):21229-34. doi: 10.1073/pnas.1113103109. Epub 2011 Dec 12.
PubMed 22160708Anderkova L, Pizem D, Klobusiakova P, Gajdos M, Koritakova E, Rektorova I. Theta Burst Stimulation Enhances Connectivity of the Dorsal Attention Network in Young Healthy Subjects: An Exploratory Study. Neural Plast. 2018 Mar 13;2018:3106918. doi: 10.1155/2018/3106918. eCollection 2018.
PubMed 29725346Novakova L, Gajdos M, Rektorova I. Theta-burst transcranial magnetic stimulation induced cognitive task-related decrease in activity of default mode network: An exploratory study. Brain Stimul. 2020 May-Jun;13(3):597-599. doi: 10.1016/j.brs.2020.01.015. Epub 2020 Jan 31. No abstract available.
PubMed 32289683Plechata A, Sahula V, Fayette D, Fajnerova I. Age-Related Differences With Immersive and Non-immersive Virtual Reality in Memory Assessment. Front Psychol. 2019 Jun 11;10:1330. doi: 10.3389/fpsyg.2019.01330. eCollection 2019.
PubMed 31244729
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel, Individualized Brain Stimulation, Network-based Approaches to Improve Cognition in Healthy Seniors and Patients With MCI
- ClinicalTrials.gov ID
- NCT04986787
- Acronym / sponsor ID
- NiBS-iCog / GF21-13462L
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Keywords
- non-invasive brain stimulation, tACS, TMS, cognition, working memory, MCI, healthy ageing, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Swiss Federal Institute of Technology
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Aug 2021 (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.
Impaired working memory (WM) plays a crucial role in normal aging, in mild cognitive impairment (MCI) and cognitive decline associated with dementia, such as Alzheimer's disease (AD). The aging-related differences in WM are hypothesized to be based on various neurobiological origins, for example alterations in the dynamic interplay between the large-scale brain networks have proven an important role. Recent studies have shown that non-invasive brain stimulation (NIBS) methods can modulate neuronal activity, plasticity and large-scale brain network interactions. The investigators hypothesize that multifocal NIBS can improve WM. By successive and concurrent stimulation of multiple brain regions of the WM network by transcranial alternating current stimulation (tACS) and/or repetitive transcranial magnetic stimulation (rTMS) the investigators will study dynamic interactions between distinct cortico-cortical and subcortico-cortical brain areas. By leveraging multimodal systems neuroscience information during multifocal stimulation, the investigators expect to acquire better mechanistic understand through which NIBS acts on the brain and improves cognitive functions, such as WM.
Detailed description
Mild cognitive impairment (MCI) describes an intermediate stage from normal cognitive functioning to dementia, and identifies a spectrum of diseases that includes impairment in both memory and non-memory cognitive domains. A deficient working memory (WM) plays a crucial role in normal aging, MCI, and cognitive decline associated with dementia, such as Alzheimer's disease (AD). WM refers to the on-line temporary storage and manipulation of information to be employed in ongoing processing, and is central to the execution of a variety of daily functions. The loss of WM efficiency related to either aging or neurodegenerative process is hypothesized to have various neurobiological roots, among which altered functioning of the fronto-parietal networks play an important role. The processing, exchange, and storing of information rely on intra- and interregional connectivity that allow neuronal populations to synchronize their firing. Based on this, intra- and cross frequency oscillatory interactions have been demonstrated as core basis for working memory processes, besides other cognitive functions. Any impairment preventing the adaptation and synchronization of the oscillatory activities within this network will inevitably lead to temporary or permanent loss of function.
In this project, based on the mentioned pathophysiological concepts, the investigators will develop and test novel, individualized, multifocal, physiology-inspired non-invasive brain stimulation (NIBS) approaches aimed at enhancing interregional processing in memory-related fronto-parieto-cerebello networks with consecutive behavioral modulation of WM processes impacting on daily life activities in aged healthy volunteers (HV) and MCI patients.
The investigators approach these aims in a step-wise manner: (1) The investigators will explore entrainment of oscillatory activity in the fronto-parietal network with transcranial alternative current stimulation (tACS) at frequencies relevant to memory encoding (theta) to boost WM in healthy seniors. (2) Then, the investigators will explore cross-frequency entrainment of interregional oscillatory interactions in the frontal and parietal target network with bifocal tACS to boost WM in healthy seniors. (3) Based on the current knowledge about the extensive involvement of the cerebellum in cognitive processes by its modulatory effects onto the fronto-parietal networks crucial for cognition, the investigators will leverage our experience in non-invasive modulation of the cerebellar outputs by means of repetitive transcranial magnetic stimulation (rTMS). rTMS over the cerebellum will be applied just before cortical entrainment to further enhance its physiological and behavioral effects. (4) Finally, the investigators will select the most effective approach from the previous work-packages to be applied in MCI patients and quantify the behavioral benefits. Besides the behavioral effects, the investigators will apply multimodal systems neuroscience approaches by means of neuroimaging (structural and functional magnetic resonance imaging; s/fMRI) and electrophysiological (Electroencephalography - EEG, transcranial magnetic stimulation - TMS) methods to determine the underlying network mechanisms and patterns of intrinsic connectivity changes. As there is significant spatial heterogeneity in fronto-parietal peak activity in healthy seniors and patients, stimulation targets will be individually defined based on fMRI. By leveraging the mechanistic aspects derived from individualized multifocal stimulation, the investigators expect to better understand the mechanisms through which NIBS techniques act on the brain and improve cognitive functions. The investigators will also test and quantify within a virtual reality (VR) task how well the intervention-driven cognitive improvement translates into daily life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - within-frequency | Experimental | Device: tACSdouble-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized fronto-parietal tACS on a visual working memory task in aged HV |
| Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - cross-frequency | Experimental | Device: tACSdouble-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized cross-frequency fronto-parietal tACS stimulation on a visual WM task in aged HV |
| Cerebellar rTMS to modify the effects of cortico-cortical, fronto-parietal tACS in HV | Experimental | Device: tACS, Device: TMSdouble-blind, randomized, sham-controlled, cross-over trial assessing the effects of cerebellar stimulation on individualized fronto-parietal tACS stimulation during a visual WM task in aged HV |
| Neuromodulation protocol in MCI patients (precise protocol to be chosen on results of previous arms) | Experimental | Device: TMS, Device: TISdouble-blind, randomized, sham-controlled, cross-over trials assessing the effects of individualized striatal TIS combined with cereberal TMS on a visual working memory task in MCI patients |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- normal cognitive performance as assessed by a cognitive screening for healthy subjects
- mild cognitive impairment as assessed by detailed cognitive testing ± positive AD diagnostic biomarkers for MCI subjects
Key exclusion criteria (1 listed)
- Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
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 |
|---|---|---|
| tACSa non-invasive brain stimulation technique that allows interaction with endogenous cortical oscillatory rhythms | Device | Cerebellar rTMS to modify the effects of cortico-cortical, fronto-parietal tACS in HV, Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - cross-frequency, Entrainment with personalized bi-focal fronto-parietal synchronized tACS in HV - within-frequency |
| TMSa noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain, it will be specifically cerebellar stimulation | Device | Cerebellar rTMS to modify the effects of cortico-cortical, fronto-parietal tACS in HV, Neuromodulation protocol in MCI patients (precise protocol to be chosen on results of previous arms) |
| TIStemporal interference stimulation targeted to striatum, a non-invasive brain stimulation technique that allows interaction with endogenous cortical oscillatory rhythms deep in the brain | Device | Neuromodulation protocol in MCI patients (precise protocol to be chosen on results of previous arms) |
Primary outcome
Working memory performance
Time frame: through study completion, an average of 1 year
We will compare the baseline-normalized reaction time and error rate of a N-back task between the real and sham stimulation condition in a cross-over design.
4 secondary outcomes
The reproducibility of the outcomes of this proof-of-concept brain stimulation in MCI between centers
Time frame: through study completion, an average of 1 year
The neural underpinning of NIBS-induced changes quantified by s/fMRI and network-based analytical approaches.
Time frame: The changes will be computed from the difference between connectivity at baseline and 1 hour post-stimulation.
The neural underpinning of NIBS-induced changes quantified by EEG.
Time frame: Baseline and 1 hour after the delivery of real or sham intervention - cross-over design.
Transfer of the acquired WM abilities during the intervention into a daily-life relevant scenario as assessed by The Virtual Supermarket Shopping Task.
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 19787522Saunders NL, Summers MJ. Attention and working memory deficits in mild cognitive impairment. J Clin Exp Neuropsychol. 2010 Apr;32(4):350-7. doi: 10.1080/13803390903042379. Epub 2009 Sep 25.
- Background: PubMed 28602658Johnson EL, Dewar CD, Solbakk AK, Endestad T, Meling TR, Knight RT. Bidirectional Frontoparietal Oscillatory Systems Support Working Memory. Curr Biol. 2017 Jun 19;27(12):1829-1835.e4. doi: 10.1016/j.cub.2017.05.046. Epub 2017 Jun 9.
- Background: PubMed 24268290Roux F, Uhlhaas PJ. Working memory and neural oscillations: alpha-gamma versus theta-gamma codes for distinct WM information? Trends Cogn Sci. 2014 Jan;18(1):16-25. doi: 10.1016/j.tics.2013.10.010. Epub 2013 Nov 19.
- Background: PubMed 26286916Kornblith S, Buschman TJ, Miller EK. Stimulus Load and Oscillatory Activity in Higher Cortex. Cereb Cortex. 2016 Sep;26(9):3772-84. doi: 10.1093/cercor/bhv182. Epub 2015 Aug 18.
- Background: PubMed 22160708Eldaief MC, Halko MA, Buckner RL, Pascual-Leone A. Transcranial magnetic stimulation modulates the brain's intrinsic activity in a frequency-dependent manner. Proc Natl Acad Sci U S A. 2011 Dec 27;108(52):21229-34. doi: 10.1073/pnas.1113103109. Epub 2011 Dec 12.
- Background: PubMed 29725346Anderkova L, Pizem D, Klobusiakova P, Gajdos M, Koritakova E, Rektorova I. Theta Burst Stimulation Enhances Connectivity of the Dorsal Attention Network in Young Healthy Subjects: An Exploratory Study. Neural Plast. 2018 Mar 13;2018:3106918. doi: 10.1155/2018/3106918. eCollection 2018.
- Background: PubMed 32289683Novakova L, Gajdos M, Rektorova I. Theta-burst transcranial magnetic stimulation induced cognitive task-related decrease in activity of default mode network: An exploratory study. Brain Stimul. 2020 May-Jun;13(3):597-599. doi: 10.1016/j.brs.2020.01.015. Epub 2020 Jan 31. No abstract available.
- Background: PubMed 31244729Plechata A, Sahula V, Fayette D, Fajnerova I. Age-Related Differences With Immersive and Non-immersive Virtual Reality in Memory Assessment. Front Psychol. 2019 Jun 11;10:1330. doi: 10.3389/fpsyg.2019.01330. eCollection 2019.
- Individual participant dataSharing planned: No. Data will be shared only within both centres
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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.
Traian Popa contact
Friedhelm C. Hummel principal investigator
Ecole Polytechnique Fédérale de Lausanne
Irena Rektorova principal investigator
CEITEC Masaryk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS, TMS and TIS in people with Mild Cognitive Impairment and Healthy Aging, run by Masaryk University at 1 site in Czechia.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monika Pupikova (+420 549 49 8313, monika.pupikova@ceitec.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory performance (time frame: through study completion, an average of 1 year). 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 NCT04986787, which also lists 8 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 25 May 2023.