LanguageLCCMPHNCT05272397
Language & Cognitive Control
A study testing Methylphenidate 20 Mg Oral Tablet, Language Task and Rest Recording in people with Language and Methylphenidate of Undetermined Intent, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
Trial summary
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, and decision making. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Language, Methylphenidate of Undetermined Intent
- What is being tested?
- Methylphenidate 20 Mg Oral Tablet, Language Task and Rest Recording
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2019to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Native Dutch speakers
- Right-handed
Who cannot join
- Current (or history of) psychiatric disorder (e.g., psychosis, mania, severe depressive disorder)
- Current (or history of) neurological disorder (e.g. m. Parkinson, epilepsy)
- Current (or history of) endocrine / metabolic disorder
- Current (or history of) cardiac or vascular disorder
- Current (or history of) blood illness (e.g. severe anaemia, porphyria)
- Current (or history of) stomach or gastrointestinal tract disease
Show all 28Show fewer
- History of autonomic failure (e.g., vasovagal reflex syncope)
- Experience of irregular sleep-wake rhythm
- Current (or history of) obstructive respiratory disease
- Current (or history of) clinically significant renal or hepatic disease
- (Recent treatment of) glaucoma
- Current (or history of) drug addiction (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 recent treatment of sudden death or ventricular arrhythmia
- Problems swallowing or problems with the oesophagus
- Frequent experience of headrush (vertigo)
- Current experience of an acute serious infection
- 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
- 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
- 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/ inadequate anticonception (for women)
- Lactose intolerance (because the placebo pill will be a lactose product)
- Language related disabilities (e.g. dyslexia, stuttering)
- Daily intense physical training
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, 6525EN
About this study
Official title: The Interaction of Cognitive Control Mechanisms and Language Processing: An Investigation With Methylphenidate
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, and decision making. Recent evidence from neurodegenerative patients and the healthy population suggested that CA also influences language processing. However, the question of what kind of influence that CA might exert on language is still open. Some previous studies have shown that CA can enhance semantic processing. In a recent study it was observed that CA agonists (i.e., methylphenidate) enhance participant's sensitivity to semantically incongruent information even when language processing was actually goal-irrelevant. On the other hand, the processing of semantically congruent information was enhanced while language processing was the goal. Moreover, consistent with some previous findings that there is a relation between participants' baseline characteristics and MPH effects, it was observed that participants with lower WM capacity benefited more from receiving methylphenidate. These results shed light on the relation between CA and language processing, 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 more general cognitive functions (e.g., WM, inhibition), and whether CA also has an influence on other aspects of language processing, such as syntactic processing. The present study aimed to further investigate the nature of the relation between CA and language processing by 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 can efficiently increase the extracellular levels of CA in the brain by blocking their reuptake.
Objective: The primary objectives are: 1) to further investigate the effect of CA on semantic processing. The study plans to examine whether MPH interacts with processing of sentence context constraints via its influence on cognitive control operations. 2) To investigate the effects of MPH on syntactic processing. More specifically, the study is interested in whether MPH has an influence on revising syntactically temporarily ambiguous sentences.
Read more
A secondary objective is to further examine the relation between MPH effects and the baseline characteristics of individual participants.
Study design: This study will use a within-subject, double-blind, placebo-controlled, randomized, crossover design.
Study population: Approximately 40 healthy native Dutch speakers between 18 and 45 years old will be recruited. All subjects will have to complete one screening session and two separate testing sessions within three different days at the Donders Centre for Cognitive Neuroimaging (DCCN).
Intervention: Participants will either orally receive a 20mg methylphenidate or placebo capsule in each of the two testing sessions. 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.
Main study parameters: 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).
Hypotheses:
Based on the previous finding that methylphenidate improves cognitive stability while it impairs flexible updating, the hypothesis is that methylphenidate will hinder participants' performance in resolving syntactic ambiguity, which requires an immediate updating and revising of an initial interpretation. This should be reflected in event-related potential (ERP) measures related to revision, namely the P600 effect is predicted to be reduced in the drug condition compared to placebo.
- Conditions
- Language, Methylphenidate of Undetermined Intent
- Being tested
- Methylphenidate 20 Mg Oral Tablet, Placebo, Language Task, Rest Recording, Go/No-Go Task
- Keywords
- Cognitive Control, Language Processing, Reading, Methylphenidate, Catecholaminergic Neurotransmitters
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate 20 Mg Oral TabletDrug
20mg methylphenidate or placebo capsule - one per session (counterbalanced) approximately 1 week apart
PlaceboDrug
20mg methylphenidate or placebo capsule - one per session (counterbalanced) approximately 1 week apart
Language TaskBehavioural
The core part of the experiment is the language task, in which the aim is to investigate two critical aspects of language processing: semantic and syntactic processing. In this task, participants will be asked to read a list of sentences.
Rest RecordingBehavioural
Brain activity in the EEG is recorded at rest with eyes open and eyes closed to obtain baseline measures of alpha power as a proxy for attention and control under conditions of drug and placebo.
Go/No-Go TaskBehavioural
A Go/No-Go task will be implemented in the study design to investigate the functional properties of spatial selective attention and response inhibition. An adapted cued Go/No-Go paradigm from Randall \& Smith (2011) will be employed.
Processing SpeedBehavioural
A speeded button response task will be included to measure participants' general processing speed. In this task, participants will be instructed to respond to a simple shape presented in the centre of the screen as fast and accurately as possible through pressing a corresponding button.
Operation SpanBehavioural
In the operation span task, participants are instructed to solve math operations (e.g., (1*2) +1=?) as soon as possible and then remember a single letter. This to-be-remembered letter is followed by either another math-word combination or a recall screen, which will show up at the end of each set. When the recall screen is presented, participants have to recall all the letters in the correct order they were presented. The experimental trials contain three sets at each set size (i.e., the number of math-word pairs), with set sizes ranging from 3 to 7 items. This results in a total of 75 sets with 75 letters and 75 math problems. The order of set sizes is random for each participant. Participants' operation span will be evaluated by the total number of letters recalled in the correct serial position regardless of whether the entire trial was recalled correctly.
Reading SpanBehavioural
Participants are instructed to judge whether a presented sentence makes sense or not. After each sentence, a to-be-remembered letter will be shown on the screen, which is followed by either another sentence-word combination or the final recall screen. The set size ranges from 3 to 7 items. At the end of each set of sentences, participants will be required to recall all the letters in the current set in order. There will be a total of 75 letters and 75 sentence judgements. The order of the set sizes will be at random for each participant. Participants' performance will be evaluated by calculating the total number of correctly recalled letter sets.
Barratt Impulsiveness ScaleBehavioural
The Barratt impulsiveness scale (BIS-11) will be used in the experiment to measure participants' trait impulsivity. Participants will be required to rate themselves on 30 items that are related to attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness.
| Study group | Role | What they receive |
|---|---|---|
| Drug Session | Active comparator | In this arm of the study participants receive the drug (Methylphenidate - 20mg), administered prior to completion of the primary and secondary tasks for the study.
Electroencephalography (EEG) is measured for the duration of the primary and secondary tasks. Participants complete both arms of the study, and the order in which participants are assigned to this and the other arm of the study is randomized. Receives: Drug: Methylphenidate 20 Mg Oral Tablet; Behavioral: Language Task; Behavioral: Rest Recording; Behavioral: Go/No-Go Task; Behavioral: Processing Speed |
| Placebo Session | Placebo comparator | In this arm of the study participants receive the a placebo, administered prior to completion of the primary and secondary tasks for the study.
Electroencephalography (EEG) is measured for the duration of the primary and secondary tasks. Participants complete both arms of the study, and the order in which participants are assigned to this and the other arm of the study is randomized. Receives: Drug: Placebo; Behavioral: Language Task; Behavioral: Rest Recording; Behavioral: Go/No-Go Task; Behavioral: Processing Speed |
| Intake Session | Other | In this arm of the study participants are screened for suitability to participate in the experiment based on specified inclusion and exclusion criteria. They also complete some baseline tasks to assess working memory capacity, impulsiveness, and subjective mood. Receives: Behavioral: Operation Span; Behavioral: Reading Span; Behavioral: Barratt Impulsiveness Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language Task ERP Drug Session
This measure will assess the P600 ERP effect (amplitude difference between correct and syntactic ambiguity conditions) just after the target word in the sentences being read.
Measured: First or second testing session depending on which session corresponds to the session where the drug was administered.
Language Task ERP Placebo Session
This measure will assess the P600 ERP effect (amplitude difference between correct and syntactic ambiguity conditions) just after the target word in the sentences being read.
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Language Task Alpha Power Drug Session
This measure will assess the alpha power effect (relative power difference between high and low sentence constraint conditions in the alpha frequency band, 8-12 Hz) just before the target word in the sentences being read.
Measured: First or second testing session depending on which session corresponds to the session where the drug was administered.
Language Task Alpha Power Placebo Session
This measure will assess the alpha power effect (relative power difference between high and low sentence constraint conditions in the alpha frequency band, 8-12 Hz) just before the target word in the sentences being read.
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Secondary outcomes (4)
Default Mode Alpha Power Drug Session
This measure will assess alpha power (8-12 Hz) at rest (relative difference between alpha power measured over the duration of the eyes open to that measured over the duration of the eyes closed recordings).
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Default Mode Alpha Power Placebo Session
This measure will assess alpha power (8-12 Hz) at rest (relative difference between alpha power measured over the duration of the eyes open to that measured over the duration of the eyes closed recordings).
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Go-NoGo Task Alpha Power Drug Session
This measure will assess alpha power (8-12 Hz) at response and no-response cues to obtain a measure of attentional control.
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Go-NoGo Task Alpha Power Placebo Session
This measure will assess alpha power (8-12 Hz) at response and no-response cues to obtain a measure of attentional control.
Measured: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start26 Nov 2019
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LanguageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Cognitive Neuroimaging
- Sponsor type
- University, hospital or other
- Collaborators
- Max Planck Institute for Psycholinguistics, Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter Hagoort, PhD, Principal investigator, Donders Centre for Cognitive Neuroimaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272397
- Sponsor's protocol ID
- NL69700.091.19
- Acronym
- LCCMPH
- Status last verified
- Feb 2022
- First submitted
- 7 Feb 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction of Cognitive Control Mechanisms and Language Processing: An Investigation With Methylphenidate
- ClinicalTrials.gov ID
- NCT05272397
- Acronym / sponsor ID
- LCCMPH / NL69700.091.19
- Conditions
- Language, Methylphenidate of Undetermined Intent
- Keywords
- Cognitive Control, Language Processing, Reading, Methylphenidate, Catecholaminergic Neurotransmitters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Donders Centre for Cognitive NeuroimagingUniversity, hospital or other
- Collaborators
- Max Planck Institute for Psycholinguistics, Radboud University Medical Center
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, and decision making. Recent evidence from neurodegenerative patients and the healthy population suggested that CA also influences language processing. However, the question of what kind of influence that CA might exert on language is still open. Some previous studies have shown that CA can enhance semantic processing. In a recent study it was observed that CA agonists (i.e., methylphenidate) enhance participant's sensitivity to semantically incongruent information even when language processing was actually goal-irrelevant. On the other hand, the processing of semantically congruent information was enhanced while language processing was the goal. Moreover, consistent with some previous findings that there is a relation between participants' baseline characteristics and MPH effects, it was observed that participants with lower WM capacity benefited more from receiving methylphenidate. These results shed light on the relation between CA and language processing, 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 more general cognitive functions (e.g., WM, inhibition), and whether CA also has an influence on other aspects of language processing, such as syntactic processing. The present study aimed to further investigate the nature of the relation between CA and language processing by 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 can efficiently increase the extracellular levels of CA in the brain by blocking their reuptake.
Objective: The primary objectives are: 1) to further investigate the effect of CA on semantic processing. The study plans to examine whether MPH interacts with processing of sentence context constraints via its influence on cognitive control operations. 2) To investigate the effects of MPH on syntactic processing. More specifically, the study is interested in whether MPH has an influence on revising syntactically temporarily ambiguous sentences.
A secondary objective is to further examine the relation between MPH effects and the baseline characteristics of individual participants.
Study design: This study will use a within-subject, double-blind, placebo-controlled, randomized, crossover design.
Study population: Approximately 40 healthy native Dutch speakers between 18 and 45 years old will be recruited. All subjects will have to complete one screening session and two separate testing sessions within three different days at the Donders Centre for Cognitive Neuroimaging (DCCN).
Intervention: Participants will either orally receive a 20mg methylphenidate or placebo capsule in each of the two testing sessions. 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.
Main study parameters: 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).
Hypotheses:
Based on the previous finding that methylphenidate improves cognitive stability while it impairs flexible updating, the hypothesis is that methylphenidate will hinder participants' performance in resolving syntactic ambiguity, which requires an immediate updating and revising of an initial interpretation. This should be reflected in event-related potential (ERP) measures related to revision, namely the P600 effect is predicted to be reduced in the drug condition compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Drug Session | Active comparator | Drug: Methylphenidate 20 Mg Oral Tablet, Behavioral: Language Task, Behavioral: Rest Recording, Behavioral: Go/No-Go Task, Behavioral: Processing SpeedIn this arm of the study participants receive the drug (Methylphenidate - 20mg), administered prior to completion of the primary and secondary tasks for the study. Electroencephalography (EEG) is measured for the duration of the primary and secondary tasks. Participants complete both arms of the study, and the order in which participants are assigned to this and the other arm of the study is randomized. |
| Placebo Session | Placebo comparator | Drug: Placebo, Behavioral: Language Task, Behavioral: Rest Recording, Behavioral: Go/No-Go Task, Behavioral: Processing SpeedIn this arm of the study participants receive the a placebo, administered prior to completion of the primary and secondary tasks for the study. Electroencephalography (EEG) is measured for the duration of the primary and secondary tasks. Participants complete both arms of the study, and the order in which participants are assigned to this and the other arm of the study is randomized. |
| Intake Session | Other | Behavioral: Operation Span, Behavioral: Reading Span, Behavioral: Barratt Impulsiveness ScaleIn this arm of the study participants are screened for suitability to participate in the experiment based on specified inclusion and exclusion criteria. They also complete some baseline tasks to assess working memory capacity, impulsiveness, and subjective mood. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Native Dutch speakers
- Right-handed
Key exclusion criteria (28 listed)
- Current (or history of) psychiatric disorder (e.g., psychosis, mania, severe depressive disorder)
- Current (or history of) neurological disorder (e.g. m. Parkinson, epilepsy)
- Current (or history of) endocrine / metabolic disorder
- Current (or history of) cardiac or vascular disorder
- Current (or history of) blood illness (e.g. severe anaemia, porphyria)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate 20 Mg Oral Tablet20mg methylphenidate or placebo capsule - one per session (counterbalanced) approximately 1 week apart | Drug | Drug Session |
| Placebo20mg methylphenidate or placebo capsule - one per session (counterbalanced) approximately 1 week apart | Drug | Placebo Session |
| Language TaskThe core part of the experiment is the language task, in which the aim is to investigate two critical aspects of language processing: semantic and syntactic processing. In this task, participants will be asked to read a list of sentences. | Behavioural | Drug Session, Placebo Session |
| Rest RecordingBrain activity in the EEG is recorded at rest with eyes open and eyes closed to obtain baseline measures of alpha power as a proxy for attention and control under conditions of drug and placebo. | Behavioural | Drug Session, Placebo Session |
| Go/No-Go TaskA Go/No-Go task will be implemented in the study design to investigate the functional properties of spatial selective attention and response inhibition. An adapted cued Go/No-Go paradigm from Randall \& Smith (2011) will be employed. | Behavioural | Drug Session, Placebo Session |
| Processing SpeedA speeded button response task will be included to measure participants' general processing speed. In this task, participants will be instructed to respond to a simple shape presented in the centre of the screen as fast and accurately as possible through pressing a corresponding button. | Behavioural | Drug Session, Placebo Session |
| Operation SpanIn the operation span task, participants are instructed to solve math operations (e.g., (1*2) +1=?) as soon as possible and then remember a single letter. This to-be-remembered letter is followed by either another math-word combination or a recall screen, which will show up at the end of each set. When the recall screen is presented, participants have to recall all the letters in the correct order they were presented. The experimental trials contain three sets at each set size (i.e., the number of math-word pairs), with set sizes ranging from 3 to 7 items. This results in a total of 75 sets with 75 letters and 75 math problems. The order of set sizes is random for each participant. Participants' operation span will be evaluated by the total number of letters recalled in the correct serial position regardless of whether the entire trial was recalled correctly. | Behavioural | Intake Session |
| Reading SpanParticipants are instructed to judge whether a presented sentence makes sense or not. After each sentence, a to-be-remembered letter will be shown on the screen, which is followed by either another sentence-word combination or the final recall screen. The set size ranges from 3 to 7 items. At the end of each set of sentences, participants will be required to recall all the letters in the current set in order. There will be a total of 75 letters and 75 sentence judgements. The order of the set sizes will be at random for each participant. Participants' performance will be evaluated by calculating the total number of correctly recalled letter sets. | Behavioural | Intake Session |
| Barratt Impulsiveness ScaleThe Barratt impulsiveness scale (BIS-11) will be used in the experiment to measure participants' trait impulsivity. Participants will be required to rate themselves on 30 items that are related to attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness. | Behavioural | Intake Session |
Primary outcome
Language Task ERP Drug Session
Time frame: First or second testing session depending on which session corresponds to the session where the drug was administered.
This measure will assess the P600 ERP effect (amplitude difference between correct and syntactic ambiguity conditions) just after the target word in the sentences being read.
Language Task ERP Placebo Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
This measure will assess the P600 ERP effect (amplitude difference between correct and syntactic ambiguity conditions) just after the target word in the sentences being read.
Language Task Alpha Power Drug Session
Time frame: First or second testing session depending on which session corresponds to the session where the drug was administered.
This measure will assess the alpha power effect (relative power difference between high and low sentence constraint conditions in the alpha frequency band, 8-12 Hz) just before the target word in the sentences being read.
Language Task Alpha Power Placebo Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
This measure will assess the alpha power effect (relative power difference between high and low sentence constraint conditions in the alpha frequency band, 8-12 Hz) just before the target word in the sentences being read.
4 secondary outcomes
Default Mode Alpha Power Drug Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Default Mode Alpha Power Placebo Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Go-NoGo Task Alpha Power Drug Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Go-NoGo Task Alpha Power Placebo Session
Time frame: First or second testing session depending on which session corresponds to the session where the placebo was administered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hagoort, PhD principal investigator
Donders Centre for Cognitive Neuroimaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate 20 Mg Oral Tablet, Language Task and Rest Recording in people with Language and Methylphenidate of Undetermined Intent, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language Task ERP Drug Session (time frame: First or second testing session depending on which session corresponds to the session where the drug was administered.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.