1) to identify the effect of manipulating the electrical synapses in the IO on motor learning in healthy individuals during cerebellar specific motor adaptation tasks. 2) to identify the effect of manipulating the subthreshold oscillations in the IO…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of the study is to determine the effect of modafinil and
fluoxetine on motor learning in healthy individuals. The participants will be
subjected to two different cerebellar specific motor adaptation paradigms: the
random saccade adaption task (motor timing independent) and the random smooth
pursuit adaptation task (motor timing dependent). The motor learning capacity
will be determined by quantifying the velocity and gain of adaptation. A
minimal drug-induced improvement of the motor learning capacity by 10% is
considered clinically relevant.
Secondary outcome
n.a.
Background summary
Motor impairments are the most common deficits caused by stroke. Although
standard rehabilitation efforts are used to facilitate recovery after stroke,
additional interventions are necessary to further improve/regain motor function
and avoid limitation in mobility. Improving motor learning capacity could aid
this rehabilitation process. Motor learning is in the brain mainly regulated
the olivo-cerebellar system. The Inferior olive (IO) is one of the major
information gateways that relay motor error signals to the cerebellum. Neurons
of the IO have very intriguing properties; they receive sensory information
(from the body) as well as feedback information from the cerebellum, they
communicate mainly with each other via electrical synapses and they generate
subthreshold oscillations. The IO can theoretically be manipulated in two ways
in order to facilitate motor learning: 1) the electrical transmission between
olivary neurons can be enhanced by using pharmacological modulators of
electrical synapses, and 2) the amplitude of the subthreshold oscillations can
be reduced by using a pharmacological serotonergic intervention. Modafinil is
known to enhance electrotonical coupling between olivary neurons and serotonin
is known to reduce the subthreshold oscillation of olivary neurons (and we
expect that fluoxetine will do the same). Although both drugs intervene on
another olivary property/mechanism, they both could potentially shorten the
rehabilitation time and help to achieve higher levels of motor performances.
In this study, we will investigate the effect of modafinil and fluoxetine (via
pharmacological manipulation of the IO) on motor learning in healthy
individuals during a cerebellar specific motor adaptation tasks.
Study objective
1) to identify the effect of manipulating the electrical synapses in the IO on
motor learning in healthy individuals during cerebellar specific motor
adaptation tasks. 2) to identify the effect of manipulating the subthreshold
oscillations in the IO on motor learning in healthy individuals during
cerebellar specific motor adaptation tasks.
Study design
Double-blind randomize placebo-controlled study
Study burden and risks
The subjects have to visit the Erasmus MC for 2 times and for a total of 6
hours (modafinil group) or 12 hours (fluoxetine group). They have to fill in
two questionnaires, do four motor tasks and one cognitive task. Subjects that
are in the modafinil group have to wait (in the relax room) for two hours,
whereas the fluoxetine group have to wait 5 hours before the start of the
motor- and cognitive tasks. The total duration of all tasks will be around 1
hour. Neither the behavioural tasks nor the single-dose of modafinil or
fluoxetine does cause a significant discomfort or risk for the subject. The
subject*s receive a financial compensation for expenses made due to
participation.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Healthy
Male
Aged 18-55 years
Informed consent obtained
Exclusion criteria
History of neurological or psychiatric disorders
History of neurosurgery
History of Sleep disorders
History or evidence of renal, gastrointestinal, hepatic or hematologic abnormalities
Using acute or chronic psychoactive drugs
Alcoholism
Smoking
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 | NL52849.078.15 |