The overall objective is to perform simulations in a computer model of the human brain to map out the optimal parameters for non-invasive brain stimulation in AD. Simulations will be performed in both general and personalised models, the latter…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurodegenerative disorders, dementia
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint consists of MEG-based measures of oscillatory brain
activity, functional connectivity and network topology, which indicate the
degree of disruption or improvement in brain functioning.
Secondary outcome
Optimal stimulation parameters as determined by the model, and working memory
scores.
Background summary
Improving disrupted brain network function in the early phase of Alzheimer*s
disease (AD) may reduce cognitive impairment, but human brain networks are
highly complex, dynamic, and patient-specific. This project will combine
computational modelling with brain stimulation and simultaneous measurement of
brain network activity to find optimal, personalised strategies for preserving
cognition in AD. Brain activity-targeting treatment development will become
more efficient and faster, and will reduce patient burden because of a more
rational, patient-specific intervention selection. This unique approach will
also contribute to a better understanding of disrupted brain activity in early
AD, to the desired further integration of neuroscience and computer modelling,
and to uniting fundamental and clinical researchers by offering an integrated
simulation/stimulation framework.
Study objective
The overall objective is to perform simulations in a computer model of the
human brain to map out the optimal parameters for non-invasive brain
stimulation in AD. Simulations will be performed in both general and
personalised models, the latter using patient-specific models based on
functional and structural connectivity results from their
magnetoencephalography (MEG) scans during clinical screening. Model predictions
will then be verified via simultaneous brain imaging during stimulation. The
hypothesis is that the stimulation will improve measures of brain network
function.
Study design
A cross-sectional, sham-controlled simulation and intervention study.
Intervention
One intervention session using transcranial direct current stimulation (tDCS)
with a simultaneous MEG recording.
Study burden and risks
MEG recording is non-invasive and involves lying in a supine position in a
shielded room. The recording procedure is not painful in any way, is not
considered to be difficult or stressful (except for patients with extreme
claustrophobia), and has negligible risks. There is no individual benefit from
the MEG. Brain stimulation using tDCS is non-invasive and uses very low (up to
2 mA) currents, therefore posing no risk. Possible transient side effects
include tingling on the scalp, dizziness or sensation of phosphenes at the
onset and outset of stimulation. There are clinical benefits associated with
tDCS, for example in the treatment of depression, but benefits are yet to be
fully established in AD.
Amsterdam UMC, locatie VUmc Ziekenhuisgebouw De Boelelaan 1117
Amsterdam 1081 HV
NL
Amsterdam UMC, locatie VUmc Ziekenhuisgebouw De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: fulfilling the diagnostic criteria for probable AD;
between 50-80 years of age; known amyloid status.
Additionally, a signed informed consent for Amsterdam Dementia Cohort (ADC)
(P2016.061) or AHR (P2016.409) is required.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: cardiac pacemakers, ICD's and other
intracorporeal devices or medication interfering with MEG-signals; severe
claustrophobia.
Design
Recruitment
Medical products/devices used
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 | NL81479.029.22 |