The primary objectives is to determine the difference in cortical inhibition and cortical plasticity between NF1 patients and unaffected controls.
ID
Source
Brief title
Condition
- Neurological disorders congenital
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Cortical inhibition as reflected by SICI using a conditioning pulse with
60%RMT intensity
- Cortical plasticity as reflected by iTBS induced increase of MEP*s over the
time course of 20 minutes after plasticity induction.
Secondary outcome
- To determine the difference in motor skill learning between NF1 patients and
unaffected controls.
- To determine the correlation between cortical inhibition and motor
skill learning
- To determine the correlation between cortical plasticity and motor skill
learning
- To determine the correlation between cortical inhibition and cortical
plasticity
- To determine whether there is a difference in cortical inhibition as
measured by the SICI (80%) TMS paradigm between adults with NF1 and unaffected
controls
- To determine whether there is a difference in cortical inhibition measured by
the CSP TMS paradigm between adults with NF1 and unaffected controls.
Background summary
Many individuals with Neurofibromatosis type 1 (NF1) suffer from cognitive and
behavioural disabilities. The underlying cause of these disabilities has been
extensively studied in Nf1 mouse models. This revealed that, at a neuronal
level, cognitive disabilities seem to be caused by an increased firing of
inhibitory interneurons and, therefore, an decreased synaptic plasticity. To
further study the role of cortical inhibition and plasticity in the cognitive
and behavioural deficits in NF1 patients we need a non-invasive method to study
these neurophysiological processes.
Study objective
The primary objectives is to determine the difference in cortical inhibition
and cortical plasticity between NF1 patients and unaffected controls.
Study design
Observational case-control study
Study burden and risks
The participants will visit the Erasmus MC once. Neuropsychological tests and
non-invasive neurophysiology measurements are assessed during this visit. Total
time investment by the participants for visits and testing will be ± 6 hours.
Previous studies concluded that TBS appears to be safe, however it should be
applied with caution (Hong et al., 2015; Oberman et al., 2011). We will make
use of a screening checklist for risk factors in order to avoid potential
TMS-related side effects. The participants will be reimbursed for travel costs
and they will receive 100,- euros. This study is aimed at studying a NF1
specific neuronal dysfunction. Thus, testing only healthy volunteers cannot
produce data that will give more insight into the functioning of the brain of
NF1 patients.
dr. Molewaterplein 50
Rotterdam 3015 GE
NL
dr. Molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
- Age 18 - 55 years at inclusion
- Oral and written informed consent
- Right-handed
- NF1 patients with a clinically confirmed diagnosis
Exclusion criteria
- Pregnancy
- Not passing the Rossi safety check-list for undergoing a TMS-measurement (Rossi et al., 2009)
- Segmental NF1
- Psychoactive agents
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 | NL59730.078.17 |