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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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.

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 groups in NCT03068884
Study groupRoleWhat they receive
Tdcs shamSham comparatorNot described
Receives: Dietary Supplement: L-Tyrosine; Dietary Supplement: Cellulose (placebo)
PlaceboPlacebo comparatorNot described
Receives: Device: Cathodal Transcranial direct current stimulation; Device: Transcranial direct current stimulation (sham)
Tdcs cathodalExperimentalNot described
Receives: Dietary Supplement: L-Tyrosine; Dietary Supplement: Cellulose (placebo)
TyrosineExperimentalNot 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.

  1. Wisconsin Card Sorting task

    Total Number of errors (e.g. 1-200)

    Measured: 2 hours for each of the four conditions

  2. 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.

  1. First posted3 Mar 2017
  2. Study start1 Mar 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Jan 2018

Resources

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)
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

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.

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