To investigate if conventional tDCS can be improved by using a new electrode configuration. To find a relation between ongoing EEG and MEP magnitude. To investigate the effect of tDCS on cortical excitability (measured with TMS), brain activity (…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Participant 1 to 20:
To explore what type of brain activity is related to motor learning and what
activity is related to simple motor action.
Participant 21 to 55:
The main objective of the study is to reproduce the findings of Fischer et al.
(2017), who demonstrated that stimulating the M1 motor network increases the
cortical excitability, assessed with TMS. Participants will receive all three
types of stimulation (conventional, motor network and sham network), separated
by at least 48 hours, for 10 minutes. Transcranial magnetic stimulation (TMS)
will be applied to assess cortical excitability at fixed time points after
stimulation. The average cortical excitability will be compared between
conditions at all time points.
Participant 56 to 105:
The main objective of the study is to investigate the influence of transcranial
direct current stimulation (tDCS) on brain activity. Participants will receive
all three types of stimulation (conventional, motor network and sham network).
Participants will be asked to execute a motor learning task before, during and
after brain stimulation. During the motor learning task, brain activity will be
measured by using electroencephalography (EEG). Before and after the motor
learning task, brain activity at rest will be measured. The three sessions will
be separated by at least 48 hours. The influence of tDCS will be investigated
by comparing brain activity before and after tDCS.
Secondary outcome
Participant 21 to 55:
To assess correlation between pre-TMS cortical activity (measured with EEG) and
TMS amplitude (TMS/EMG). To assess the relation between tDCS-induced changes in
TMS excitability and EEG signals.
Participant 56 to 105:
To investigate the influence of transcranial direct current stimulation (tDCS)
on motor learning.
Background summary
About 80% of stroke patients suffer motor impairments. The first months of
rehabilitation are critical to regain motor function and avoid limitations in
mobility. Therefore, optimising the effects of early motor therapy in stroke
patients is crucial for their quality of life. Transcranial Direct Current
Stimulation (tDCS) is a form of non-invasive electric stimulation where a weak
current is applied through electrodes on the scalp. The effectiveness and
working mechanism of tDCS is not yet completely known, but numerous studies
demonstrate positive effects on cortical excitability and motor learning.
Recently, a multi-electrode array to stimulate the entire motor network was
proposed and found to introduce higher motor evokted potential amplitudes than
the conventional way of stimulation. In the present study, we would like to
reproduce these results in a larger sample of the healthy population.
Additionally, we would like to investigate the relation between background
cortical activity and the magnitude of the cortical excitability. Furthermore,
we would like to investigate the effect of tDCS on brain activity and motor
learning. The study will give guidelines on the steps to take to improve the
effectiveness of tDCS in motor recovery after stroke.
Study objective
To investigate if conventional tDCS can be improved by using a new electrode
configuration. To find a relation between ongoing EEG and MEP magnitude. To
investigate the effect of tDCS on cortical excitability (measured with TMS),
brain activity (recorded with EEG) and motor learning.
Study design
Single-blinded, randomised repeated-measures design
Intervention
Participant 21 to 55: Subjects receive conventional, motor network or sham
network tDCS over the motor cortex for 10 minutes at an intensity of no more
than 2 mA per electrode and at most 4 mA in total in the sessions where
cortical excitability is assessed. Subjects receive conventional, motor network
or sham network tDCS over the motor cortex for 10 minutes at an intensity of no
more than 2 mA per electrode and at most 4 mA in total.
Participant 56 to 105:
Subjects receive conventional, motor network or sham network tDCS over the
motor cortex for 10 minutes at an intensity of no more than 2 mA per electrode
and at most 4 mA in total.
Study burden and risks
Participant 1 to 20:
Participants are asked to visit the Erasmus MC once for 2.5 hours. During the
experimental session, EEG and EMG are applied, after which test subjects
perform the motor task for about 90 minutes. The burden on the participants is
small. During the motor task, participants have the opportunity to pause if
they need it. Participants are compensated for travel expenses and additionally
receive financial compensation for participation.
Participant 21 to 55:
Participants are asked to provide a saliva sample for BDNF analysis,
demonstrated to be a determinant for tDCS effectiveness, and have to visit the
Erasmus Medical Centre up to three times for the different stimulation
configurations. Each session takes up to 150 minutes. During each session,
subjects will receive conventional, motor network or sham network stimulation
over the motor cortex. TDCS is reported to be safe; side effects are mild.
Transcranial magnetic sitmulation (TMS) has been proven to be a safe method.
There is little to no risk involved in the application of single pulse TMS.
Discomfort can be experienced by the participants due to the muscle twitches
and sounds generated by TMS. There will be financial compensation for travel
expenses and participation.
Participant 56 to 105:
Participants are asked to visit the Erasmus MC three times. Each session takes
up to 2.5 hours. During the first session, participants are asked to provide a
saliva sample for BDNF analysis, because it is demonstrated that the BDNF
polymorphism can be a determinant for tDCS effectiveness. During the
experimental session, EEG, EMG and EOG are applied and participants are asked
to execute a motor learning task, which takes approximately 45 minutes. The
burden on the participants is small. During the motor learning task,
participants have the opportunity to pause if they need it. During each
session, subjects will receive conventional, motor network or sham network
stimulation over the motor cortex. tDCS is reported to be safe; side effects
are mild. Participants are compensated for travel expenses and additionally
receive financial compensation for participation.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
Age between 18-35 years
Healthy (no history of neurological disorders)
Right-handedness
Exclusion criteria
History of neurological or psychiatric disorders
Implants or metal parts in the head
Usage of medication or drugs that effect the nervous system
Neuromodulatory stimulation in the last month
Pregnancy
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 | NL64529.078.18 |