Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients on skill learning 24 hours later.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main objective of the study is to determine the effect of late plasticity
tDCS on skill learning 24 hours later. As a motor learning paradigm, we will
use a circuit tracking task which chronic stroke patients perform better if
tDCS is applied concurrently. During this task, patients have to trace a cursor
over a circuit as fast and accurate as possible by moving a computer mouse.
Skill will be quantified by calculating a combined speed/ accuracy score and
compared between sham, conventional unpaired tDCS, conventional paired tDCS and
late LTP-like plasticity tDCS groups.
Secondary outcome
• To compare excitability changes following late plasticity tDCS in stroke
patients with concurrent tDCS stimulation and sham stimulation
• To identify improvement in arm/ hand functions unrelated to skill learning
and generalization of skill learning to a new circuit with the same arm/hand.
• To determine the main effect of several polymorphisms known to be involved in
plasticity on skill learning.
• To determine if skill learning with the unaffected arm correlates with skill
learning with the affected arm.
Background summary
About 80% of stroke patients suffer motor impairments, but current therapies
have very limited effects on motor recovery. Therefore, investigating new
potential therapeutic approaches is crucial. Transcranial Direct Current
Stimulation (tDCS) is a form of non-invasive electrical stimulation where a
weak current is applied through electrodes over the scalp. This stimulation is
known to (1) induce changes in neuronal excitability -which can last up to one
day with late LTP-like plasticity protocols- in a polarity and site-specific
manner, and (2) facilitate motor learning and stroke recovery. However, it is
unknown how the motor cortex excitability changes that follow tDCS relate to
the increased learning/ recovery potential. The currently upheld hypothesis is
that motor learning needs to be synchronized in time with electrical
stimulation, but recent results from our lab suggest that tDCS also increases
skill learning after stimulation has ended. If this is true, tDCS has a much
larger therapeutic window and is a more valuable clinical tool than currently
believed. Therefore, we want to investigate how late plasticity tDCS affects
the increase in skill learning normally seen with tDCS when applied 24 hours
before training. The outcome of this study can provide important guidelines on
effective motor therapy during stroke rehabilitation.
Study objective
Identify the effect of late LTP-like plasticity tDCS in chronic stroke patients
on skill learning 24 hours later.
Study design
Double-blinded, randomized between-subjects trials.
Intervention
tDCS will be administered with a CE-certified stimulator (DC-Stimulator Plus,
neuroConn, Germany; CE 0118). The different stimulation protocols are: 30
seconds stimulation at t=0 and t=34 minutes (sham), 20 min. anodal
bihemispheric stimulation and 30 seconds of sham stimulation at t=36 minutes
(conventional tDCS) and 10 min. anodal - 25 min. pause - 10 min. anodal
bihemispheric stimulation (late LTP-like plasticity tDCS). All stimulation
sessions include a 30 second ramp-up and a 30 second ramp-down period to ensure
comfort.
With regards to blinding, all stimulation protocols will run for 47
minutes during which the device will show the impedance between the two
electrodes. Second, it is possible to program the device for each participant,
ensuring that the participant and experimenter are blinded for experimental
condition.
Study burden and risks
Before start of the experiments, subjects provide a sputum sample to assess the
presence of the common BDNF and COMT polymorphisms.
Subjects will undergo low frequency transcranial magnetic stimulation (days 1,
2 and 9) and transcranial direct current stimulation (days 1 and 2) of the
motor cortex and will perform several motor tasks (days 1, 2 and 9). At the end
of each experiment, a questionnaire on discomfort and concentration will be
handed for the subjects to fill out.
tDCS will be administered with a CE-certified stimulator (DC-Stimulator Plus,
neuroConn, Germany; CE 0118). The different stimulation protocols are: 90
seconds stimulation (sham), 20 min. anodal bihemispheric stimulation
(conventional tDCS) and 10 min. anodal - 25 min. pause - 10 min. anodal
bihemispheric stimulation (late plasticity tDCS).
Subjects will be asked not to drink coffee on the day of the experiments
because this could influence motor cortical excitability.
There will be financial compensation for expenses related to participation.
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Dr Molewaterplein 50
Rotterdam 3015GE
NL
Listed location countries
Age
Inclusion criteria
Chronic (> 6 months) stroke patient
Aged 18-80 years
Motor deficit in the upper limb due to the stroke
Exclusion criteria
Being unable to perform the task or to understand the instructions/ apraxia
Presence of intracranial metal
Epilepsy
Alcoholism
Cognitive impairment, or psychiatric disorder
History of psychiatric disorders
Taking acute or chronic psychoactive drugs
Absence of recordable MEPs after TMS
Hemineglect
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 | NL48838.078.14 |