Our primary objectives are: 1) to further investigate the effect of CA on semantic and syntactic processing during sentence comprehension; 2) to investigate the effect of CA on the general cognitive control ability, and further evaluate whether…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Cognitive and attention disorders and disturbances
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters include participants' task behavioral performance
(e.g. accuracy, reaction times) and electroencephalographic (EEG) measures.
Secondary outcome
Secondary study parameters include participants' baseline characteristics (e.g.
working memory capacity, linguistic experience), and general processing speed.
Background summary
One of the hottest topics in the psycholinguistics research is the relationship
between individuals* general cognitive control ability and language processing
efficiency. However, the nature of such a relationship remains unclear, such as
when and how cognitive control operations are recruited during language
processing, and whether there is a causal interplay between these two cognitive
operations. Recent studies have shown that both cognitive control and language
processing are affected by the individuals* catecholaminergic (CA) level. We
proposed that investigating the role of CA for language and cognitive control
operations via a pharmacological manipulation, would provide a causal link to
understand the nature of the relationship between these two most essential
human abilities.
Catecholamine (CA) neurotransmitters, such as dopamine (DA) and noradrenaline
(NA), have long been implicated playing a critical role in cognitive functions,
such as working memory (WM), inhibition, learning, decision making, and
language processing. However, the question of what kind of influence that CA
might exert on language is still open. In a recent study, through the
administration of a CA agonist (i.e., methylphenidate), Tan and Hagoort (in
preparation) found that increased CA level enhanced participant*s sensitivity
to semantically incongruent information even when language processing per se
was actually goal irrelevant. Moreover, the results showed that participants
with lower cognitive control capacity benefited more from MPH administration.
These results shed light on the relation among language processing, cognitive
control, and catecholaminergic level, but also lead to further questions, such
as whether the interaction between CA and semantic processing is
language-specific or mediated by the relation between CA and the general
cognitive control ability, and whether CA also has influence on other aspects
of language processing, such as syntactic processing.
In the present study, we aim to further investigate the nature of the
interplays between language, cognitive control and CA level through
administrating methylphenidate (MPH) to healthy participants. MPH is an
indirect CA agonist, which is the most commonly prescribed drug for attention
deficit/hyperactivity disorder (ADHD). Previous studies have shown that MPH
could efficiently increase the extracellular levels of CA in the brain by
blocking their reuptake.
Study objective
Our primary objectives are: 1) to further investigate the effect of CA on
semantic and syntactic processing during sentence comprehension; 2) to
investigate the effect of CA on the general cognitive control ability, and
further evaluate whether there is a causal relationship of cognitive control
and language processing.
Our secondary objective is to further examining the relation between the MPH
effects and the baseline characteristics (e.g., as eye-blink rate, WM capacity)
of individual participants.
Study design
This study will use a within-subject, double-blind, placebo-controlled,
randomized, crossover design, similar to CMO-approved protocol 2010/283,
2013/568, and 2015/1532. Participants will either orally receive a 20mg
methylphenidate or placebo capsule in each session. Methylphenidate has been
approved for clinical use in the Netherlands and the drug can be administered
safely without any relevant risk of serious adverse events. Primary study
parameters will include sentence comprehension capacity, attention and
processing speed. In addition, several other measures will be included to
monitor participants* baseline characteristics (e.g. working memory capacity,
vocabulary size) and the general modulation effects of MPH (e.g. heart rate,
blood pressure, subjective feeling).
Intervention
Not applicable.
Study burden and risks
Participants will have to visit the laboratory site three times. During each
visit they will have to complete a series of language and cognitive function
tasks after receiving 20mg methylphenidate or placebo. In the information
brochure shared with each participant at least 1 week before their first visit,
they will be instructed to adhere to some simple restrictions regarding
medication (especially recreational drugs), alcohol and drug intake. In the
morning of each visit they will have to refrain from smoking and
stimulant-containing drinks. The most common side effects of methylphenidate
include headache, dizziness, nausea and anxiety1. However, previous studies
conducted at the DCCN (CMO2013/568, ABR number NL47166.091.13; CMO2014/289, ABR
number NL49516.091.14; CMO2015/1532, ABR number NL51075.091.14) have shown that
a single dose of 20mg (or even higher) methylphenidate is well tolerated in
healthy adults. Considering the extensive exclusion criteria, screening
procedure and constant monitoring of the subjects, we do not expect serious
side effects.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers between 18 and 45 years old;
Native Dutch speakers.
Right-handed
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• (History of) psychiatric treatment;
• (History of) psychosis or mania;
• (History of) neurological diseases (e.g. Parkinson, epilepsie);
• (History of) neurological treatment;
• (History of) endocrine treatment;
• (History of) cardiac or vascular diseases;
• (History of) blood illness (e.g. anemia, porphyria);
• (History of) endocrine / metabolic disease;
• (History of) of stomach or gastrointestinal tract disease;
• (History of) vasovagale reflex syncope;
• Experience of irregular sleep-wake rhythm;
• (History of) obstructive respiratory disease
• (History of) frequent autonomic failure (e.g. vasovagal reflex syncope);
• (History of) clinically significant renal or hepatic disease;
• (History of) epilepsy in adulthood (i.e. no insult after 18 years of age, no current medication for epilepsy, and no insult in the last five years);
• (History of) glaucoma;
• (History of) drug addication (e.g. opiate, (meth)amphetamine, lysergic acid diethylamide, cocaine, solvents or barbiturate) or alcohol dependence;
• One first degree or two or more second degree family members with a history of sudden death or ventricular arrhythmia;
• Problems slicking or problems with the esophagus ();
• Frequent experience of headrush (vertigo);
• Past or current treatment of hyperthyroidism;
• Current experience of an acute infection (e.g. fever);
• First degree family member with schizophrenia or bipolar disorder;
• Abnormal hearing or (uncorrected) vision;
• Use of psychotropic medication or recreational drugs weekly or more over a period of more than three months in the last 6 months;
• Use of drug within 2 weeks prior to the start of the study;
• Use of alcohol within the last 24 hours before each test session;
• Dependence on cannabis or weekly cannabis usage for the last 6 months;
• Strong smoking behaviour starting at more than 1 package of cigarettes per week;
• Hypersensitivity for e.g. beta blockers or methylphenidate;
• Previous use of Methylphenidate (Ritalin);
• Uncontrolled hypertension, defined as diastolic blood pressure at rest >95 mmHg or systolic blood pressure at rest >180 mmHg;
• Irregular sleep/wake rhythm (e.g. regular nightshifts or cross timeline travel);
• Possible pregnancy or breastfeeding;
• Lactose intolerance (because the placebo pill will be a lactose product);
• Language related disabilities (e.g. dyslexia, stuttering);
• Daily intense physical training.
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 | NL69700.091.19 |