To explore the effect of reversible virtual lesions on cognitive functioning in the domain of executive functioning and on network organization / to define local network resilience and the interplay between local resilience and global network…
ID
Source
Brief title
Condition
- Other condition
- Neurological disorders NEC
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary effect of rTMS will be assessed through the change in performance
on a neuropsychological test measuring executive functioning in the domain of
executive functioning pre- and post-intervention.
Secondary outcome
Secondarily, changes in network organization will be characterised by
(multimodal) neuroimaging pre- and post-treatment. Pre-treatment imaging will
include magnetoencephalography (MEG), diffusion MRI (dMRI), task-based
functional MRI (tbfMRI), and resting state fMRI (rsfMRI); post-treatment
imaging will include only tbfMRI.
Background summary
Lesional brain disease, such as glioma or MS, is usually progressive. Patients
often suffer from cognitive decline, mainly in the domain of executive
functioning, impacting not only their quality of life but also that of their
caregivers. However, the impact of lesions is seemingly unpredictable: some
patients may show relative stability of cognitive functioning despite the
occurrence of severely progressive lesions, while others decline rapidly after
only minor disease progression. To study the individualized impact of new
lesions on the brain network and on cognition, reversible *virtual lesions* can
be induced in healthy subjects by perturbing parts of the brain through
low-frequency repetitive transcranial magnetic stimulation (rTMS). The idea is
that lesions occurring in areas that are strong local (but not global) hubs
pre-TMS, are associated with greater cognitive decline and greater global
network deviation post-TMS.
Study objective
To explore the effect of reversible virtual lesions on cognitive functioning in
the domain of executive functioning and on network organization / to define
local network resilience and the interplay between local resilience and global
network deviation.
Study design
Experimental study using single-session rTMS (versus sham). Healthy volunteers
will be randomly assigned to either an intervention or a control group, with
pre- and post-neuroimaging and cognitive testing.
Intervention
50 will undergo a single session of inhibitory rTMS to the dorsolateral
prefrontal cortex (DLPFC); 50 will be active controls (through use of a sham
coil).
Study burden and risks
Participants will visit the outpatients* clinic where they will first undergo
neuroimaging, cognitive assessment, and TMS motor threshold testing;
subsequently, participants will undergo either inhibitory rTMS or sham rTMS,
after which they will undergo task fMRI and simultaneous cognitive assessment.
Inhibitory rTMS is a non-invasive, well-tolerated technique to infer virtual
lesions. Possible side effects include transient headache (moderate risk), and
syncope, transient hearing changes, transient unintended
cognitive/neuropsychological effects, and seizure (all low risk; note that risk
of seizure in healthy controls in combination with low-frequency stimulation is
negligible). Overall, risk to participants is considered to be low,
particularly if exclusion criteria are adhered to. Lesional brain disease has a
significant impact not only on the patients suffering from it and their
caregivers but also on society, and obtaining a better understanding of the
effect of new lesions on the brain network and cognition could help inform
future studies into such diseases and might provide a first step towards
intervention/treatment. Therefore, in our view, there is negligible risk
associated with the participation of healthy, motivated volunteers, whereas the
potential value of this study is significant.
De Boelelaan 1108
Amsterdam 1081HZ
NL
De Boelelaan 1108
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
* Age between 20 and 65 years old
* Native Dutch speaker
* Able to provide written informed consent.
Exclusion criteria
* Current diagnosis of neurological or psychiatric disease (including traumatic
head injury)
* Current and regular use of centrally acting drugs (recreational or
prescribed, including analgesics), including use of alcohol ~8 hours prior to
an appointment
* Presence of any contraindications for MRI, MEG, or TMS (including
resting-motor threshold >75% of maximum stimulator output or no useful
motor-evoked potential elicitable)
* Previous rTMS treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82268.029.22 |