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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03462303
Other study ID # SheffieldHallamAquili2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date June 30, 2018

Study information

Verified date September 2018
Source Sheffield Hallam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The dorsolateral prefrontal cortex (dlPFC) and dopamine (DA) have been implicated in the control of cognitive flexibility. However, while a great deal of what it is know regarding a causative relationship between cognitive flexibility and its neuronal underpinning comes from animal studies, human data have largely been correlational (i.e. imaging investigations). In a recent study, the current research group examined whether putative increases in dopamine levels through tyrosine administration and blockage of these by cathodal (i.e. inhibitory) transcranial direct current stimulation (tDCS) of the dlPFC could be causally related to cognitive flexibility as measured by task switching and reversal learning.

The next step involves finding a way of lowering dopamine concentrations while anodal (i.e. excitatory) stimulation of the dlPFC is applied and cognitive flexibility measured. One experimental approach to reduce global DA synthesis and transmission is through acute phenylalanine and tyrosine depletion (APTD). This dietary intervention involves the administration of an amino-acid mixture lacking in tyrosine and phenylalanine, which can be used to selectively lower DA synthesis in humans.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- Either male or female

- You are aged between 18 and 30 years

- You are in good health

- You agree to fast overnight prior to testing

Exclusion Criteria:

- Are suffering from cardiac, hepatic, renal, or neurological disorders

- Damaged or diseased skin on your face and scalp, or a sensitive scalp

- A history of alcohol or drug addiction, or severe psychiatric illness

- Are in drug treatment which may lower seizure threshold (i.e. epilepsy)

- You are pregnant

- Slept less than 6 hours prior to coming to the lab

- Suffer from phenylketonuria

- A history of or current experience of migraine or headaches

- A history of or current use of antidepressants

- A history of or current use of tyrosine supplements

- Consume more than five beverages containing caffeine per day

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Sham tDCS and tyrosine depleted drink
Transcranial direct current stimulation (sham) of the dlPFC in combination with a tyrosine and phenylalanine free product.
Anodal tDCS and tyrosine depleted drink
Transcranial direct current stimulation (anodal) of the dlPFC in combination with a tyrosine and phenylalanine free product.
Sham tDCS and balanced drink
Transcranial direct current stimulation (sham) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.
Anodal tDCS and balanced drink
Transcranial direct current stimulation (anodal) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.

Locations

Country Name City State
United Kingdom Department of Psychology labs Sheffield South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
Sheffield Hallam University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cognitive flexibility performance Measured using Wisconsin Card Sorting Test Measured over 5 hours four times.1st measurement taken at baseline (i.e. time 0). 2nd measurement taken 120 minutes after measurement 1. 3rd measurement taken 220 minutes after measurement 1. 4th measurement taken 270 minutes after measurement 1.
Primary Change in cognitive flexibility performance Measured using Probabilistic Reversal Learning Measured over 5 hours. 1st measurement taken at baseline (i.e. time 0). 2nd measurement taken 120 minutes after measurement 1. 3rd measurement taken 220 minutes after measurement 1. 4th measurement taken 270 minutes after measurement 1.
See also
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