NCT03462303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

February 20, 2018

Last Update Submit

September 10, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (4)

tDCS sham + balanced drink

PLACEBO COMPARATOR
Combination Product: Sham tDCS and balanced drink

tDCS sham + tyrosine depleted drink

EXPERIMENTAL
Combination Product: Sham tDCS and tyrosine depleted drink

tDCS anodal + balanced drink

EXPERIMENTAL
Combination Product: Anodal tDCS and balanced drink

tDCS anodal +tyrosine depleted drink

EXPERIMENTAL
Combination Product: Anodal tDCS and tyrosine depleted drink

Interventions

Transcranial direct current stimulation (sham) of the dlPFC in combination with a tyrosine and phenylalanine free product.

tDCS sham + tyrosine depleted drink

Transcranial direct current stimulation (anodal) of the dlPFC in combination with a tyrosine and phenylalanine free product.

tDCS anodal +tyrosine depleted drink
Sham tDCS and balanced drinkCOMBINATION_PRODUCT

Transcranial direct current stimulation (sham) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.

tDCS sham + balanced drink

Transcranial direct current stimulation (anodal) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.

tDCS anodal + balanced drink

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology labs

Sheffield, South Yorkshire, S10 2BQ, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

March 12, 2018

Study Start

February 12, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations