Cognitive ChangeNCT03068884
Dopamine Dorsolateral Prefrontal Cortex Behavioural Flexibility
A study testing Cathodal Transcranial direct current stimulation and L-Tyrosine in people with Cognitive Change, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
Behavioural or cognitive flexibility (BF) is an essential ability which allows an organism to adaptively change responses in accordance with feedback of results. In humans, this ability is disrupted among those who suffer a variety of neurological and psychiatric conditions including Parkinson's disease… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Cathodal Transcranial direct current stimulation and L-Tyrosine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2017to 31 Jan 2018
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 30 years
- In good health
- Agrees to fast overnight prior to testing
Who cannot join
- Presence of cardiac, hepatic, renal, or neurological disorders
- Presence of damaged or diseased skin on your face and scalp, or a sensitive scalp
- A history of alcohol or drug addiction, or severe psychiatric illness
- Taking drugs which may lower seizure threshold (i.e. epilepsy)
- In a state of pregnancy
- Having slept less than 6 hours the night before testing
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- A history of migraine or headaches
- A history of taking antidepressants
- A history of taking tyrosine supplements
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Psychology laboratories
Sheffield, Yorkshire, S10 2BQ
About this study
Official title: Dopaminergic Contribution to Behavioural Flexibility as Modulated by Transcranial Direct-current Stimulation of the Dorsolateral Prefrontal Cortex
Behavioural or cognitive flexibility (BF) is an essential ability which allows an organism to adaptively change responses in accordance with feedback of results. In humans, this ability is disrupted among those who suffer a variety of neurological and psychiatric conditions including Parkinson's disease, schizophrenia, addiction, obsessive compulsive disorder and autism. Additionally, there is evidence of substantial individual differences in BF within the healthy population.
Two known neurobiological mechanisms which relate to BF performance are variation in dopamine (DA) and serotonin (SE) function. One particular brain regions which has been heavily implicated in BF is the prefrontal cortex (PFC), with the dorsolateral PFC receiving a largely DA innervation and the dorsomedial PFC a SE input. Studies have demonstrated that damage to parts of PFC including the orbitofrontal cortex (OFC), for example, impairs reversal learning (a form of BF) whereas lesions of the dorsolateral PFC affect attentional set-shifting (another measure of BF).
Read more
In humans, putative augmentation of DA efflux via administration of the DA and norepinephrine precursor tyrosine has been shown to improve task-switching performance, and inhibitory control suggesting a causal role of DA in regulating BF. Similarly, putative depletion of serotonin neurotransmission via tryptophan depletion procedures has been shown to reduce the BOLD response during performance monitoring and increase perseverative behaviour.
One important strategy (in humans) to observe whether the PFC is causally involved in BF performance, is by reversible electrical stimulation of the PFC, so that PFC cells could be inhibited or excited while a participant is performing a BF task. In recent years, several laboratories have taken advantage of a relatively new technology known as transcranial direct current stimulation (tDCS) to study the relationship between brain function and behaviour. Using this technique, increases or decreases in cortical excitability are partly determined by the polarity of the stimulation; increases occur under the anode electrode whereas decreases occur under the negatively charged cathode.
Using this approach, several studies have shown that anodal and cathodal stimulation over the PFC can have a number of effects on BF performance, with general improvements during anodal stimulation and impairments during cathodal. If this is the case, one important step that remains to be understood is whether dopamine and serotonin are causally related to these outcomes when neurons of the dLPFC/dMPFC are either excited or inhibited via tDCS.
Thus, the specific novelty of this study rests in combining a psychopharmacological approach (i.e. tyrosine/tryptophan loading) with selective neuroanatomical (i.e. dorsolateral/dorsomedial prefrontal cortex) inhibition of cells via tDCS while participants are performing BF tasks. By doing so, we will be able to establish whether increased dopaminergic/serotonergic output to the PFC is a necessary requirement for BF performance.
- Conditions
- Cognitive Change
- Being tested
- Cathodal Transcranial direct current stimulation, L-Tyrosine, Transcranial direct current stimulation (sham), Cellulose (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cathodal Transcranial direct current stimulationDevice
Cathodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
L-TyrosineDietary supplement
Administration of 2 grams tyrosine
Transcranial direct current stimulation (sham)Device
Sham tDCS
Cellulose (placebo)Dietary supplement
Administration of 2 grams cellulose
| Study group | Role | What they receive |
|---|---|---|
| Tdcs sham | Sham comparator | Not described Receives: Dietary Supplement: L-Tyrosine; Dietary Supplement: Cellulose (placebo) |
| Placebo | Placebo comparator | Not described Receives: Device: Cathodal Transcranial direct current stimulation; Device: Transcranial direct current stimulation (sham) |
| Tdcs cathodal | Experimental | Not described Receives: Dietary Supplement: L-Tyrosine; Dietary Supplement: Cellulose (placebo) |
| Tyrosine | Experimental | Not described Receives: Device: Cathodal Transcranial direct current stimulation; Device: Transcranial direct current stimulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wisconsin Card Sorting task
Total Number of errors (e.g. 1-200)
Measured: 2 hours for each of the four conditions
Probabilistic reversal learning task
Mean Errors per reversal (e.g. 1-20)
Measured: 2 hours for each of the four conditions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Aquili, Ph.D., Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068884
- Sponsor's protocol ID
- SheffieldHallamAquili2017
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Contribution to Behavioural Flexibility as Modulated by Transcranial Direct-current Stimulation of the Dorsolateral Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT03068884
- Acronym / sponsor ID
- SheffieldHallamAquili2017
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 3 Mar 2017 (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.
Behavioural or cognitive flexibility (BF) is an essential ability which allows an organism to adaptively change responses in accordance with feedback of results. In humans, this ability is disrupted among those who suffer a variety of neurological and psychiatric conditions including Parkinson's disease, schizophrenia, addiction, obsessive compulsive disorder and autism. Additionally, there is evidence of substantial individual differences in BF within the healthy population.
Two known neurobiological mechanisms which relate to BF performance are variation in dopamine (DA) and serotonin (SE) function. One particular brain regions which has been heavily implicated in BF is the prefrontal cortex (PFC), with the dorsolateral PFC receiving a largely DA innervation and the dorsomedial PFC a SE input. Studies have demonstrated that damage to parts of PFC including the orbitofrontal cortex (OFC), for example, impairs reversal learning (a form of BF) whereas lesions of the dorsolateral PFC affect attentional set-shifting (another measure of BF).
In humans, putative augmentation of DA efflux via administration of the DA and norepinephrine precursor tyrosine has been shown to improve task-switching performance, and inhibitory control suggesting a causal role of DA in regulating BF. Similarly, putative depletion of serotonin neurotransmission via tryptophan depletion procedures has been shown to reduce the BOLD response during performance monitoring and increase perseverative behaviour.
One important strategy (in humans) to observe whether the PFC is causally involved in BF performance, is by reversible electrical stimulation of the PFC, so that PFC cells could be inhibited or excited while a participant is performing a BF task. In recent years, several laboratories have taken advantage of a relatively new technology known as transcranial direct current stimulation (tDCS) to study the relationship between brain function and behaviour. Using this technique, increases or decreases in cortical excitability are partly determined by the polarity of the stimulation; increases occur under the anode electrode whereas decreases occur under the negatively charged cathode.
Using this approach, several studies have shown that anodal and cathodal stimulation over the PFC can have a number of effects on BF performance, with general improvements during anodal stimulation and impairments during cathodal. If this is the case, one important step that remains to be understood is whether dopamine and serotonin are causally related to these outcomes when neurons of the dLPFC/dMPFC are either excited or inhibited via tDCS.
Thus, the specific novelty of this study rests in combining a psychopharmacological approach (i.e. tyrosine/tryptophan loading) with selective neuroanatomical (i.e. dorsolateral/dorsomedial prefrontal cortex) inhibition of cells via tDCS while participants are performing BF tasks. By doing so, we will be able to establish whether increased dopaminergic/serotonergic output to the PFC is a necessary requirement for BF performance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tdcs sham | Sham comparator | Dietary Supplement: L-Tyrosine, Dietary Supplement: Cellulose (placebo) |
| Placebo | Placebo comparator | Device: Cathodal Transcranial direct current stimulation, Device: Transcranial direct current stimulation (sham) |
| Tdcs cathodal | Experimental | Dietary Supplement: L-Tyrosine, Dietary Supplement: Cellulose (placebo) |
| Tyrosine | Experimental | Device: Cathodal Transcranial direct current stimulation, Device: Transcranial direct current stimulation (sham) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 30 years
- In good health
- Agrees to fast overnight prior to testing
Key exclusion criteria (9 listed)
- Presence of cardiac, hepatic, renal, or neurological disorders
- Presence of damaged or diseased skin on your face and scalp, or a sensitive scalp
- A history of alcohol or drug addiction, or severe psychiatric illness
- Taking drugs which may lower seizure threshold (i.e. epilepsy)
- In a state of pregnancy
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 |
|---|---|---|
| Cathodal Transcranial direct current stimulationCathodal transcranial direct current stimulation over the dorsolateral prefrontal cortex | Device | Placebo, Tyrosine |
| L-TyrosineAdministration of 2 grams tyrosine | Dietary supplement | Tdcs cathodal, Tdcs sham |
| Transcranial direct current stimulation (sham)Sham tDCS | Device | Placebo, Tyrosine |
| Cellulose (placebo)Administration of 2 grams cellulose | Dietary supplement | Tdcs cathodal, Tdcs sham |
Primary outcome
Wisconsin Card Sorting task
Time frame: 2 hours for each of the four conditions
Total Number of errors (e.g. 1-200)
Probabilistic reversal learning task
Time frame: 2 hours for each of the four conditions
Mean Errors per reversal (e.g. 1-20)
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 22 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Luca Aquili, Ph.D. principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cathodal Transcranial direct current stimulation and L-Tyrosine in people with Cognitive Change, run by Sheffield Hallam University at 1 site in United Kingdom.
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 3 inclusion and 9 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 22 Feb 2018. 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 United Kingdom. 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?
Wisconsin Card Sorting task (time frame: 2 hours for each of the four conditions). The study lists 2 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 22 Feb 2018.