NCT03393312

Brief Summary

This project will test whether transcranial direct current stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) can alter reward learning behaviour in subclinical depression. tDCS is a neuromodulation technique that uses weak electrical current to increase (anodal stimulation) or decrease (cathodal stimulation) the excitability of the stimulated brain region. A growing body of evidence indicates that repeated administration of prefrontal tDCS can ameliorate symptoms of depression. A main characteristic of depression is that patients show a bias towards processing negative relative to positive information. Previously, we have found that a single session of prefrontal tDCS applied during task performance increased learning rate for reward outcomes in healthy adults. Here, we will test whether stimulation induces a similar behavioural effect in individuals with subclinical depression. We will test the prediction that tDCS will increase learning rates for reward outcomes in a reinforcement learning task. The findings will contribute to understanding the cognitive effects of prefrontal tDCS in subclinical depression. The ultimate aim, to be explored through further studies, is to understand and improve how tDCS might be used in the treatment of depressive disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 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

First Submitted

Initial submission to the registry

December 22, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

3.8 years

First QC Date

December 22, 2017

Last Update Submit

November 19, 2024

Conditions

Keywords

Transcranial direct current stimulationBiological PsychiatryDepressionDecision-making

Outcome Measures

Primary Outcomes (2)

  • Change in learning rate

    In our previous study (Overman et al., 2021), model comparison showed that participants' behaviour on this task was best fit by a computational model combining: a Rescorla-Wagner learning rule with a Softmax function, including two separate learning rates for wins and losses; an inverse temperature parameter accounting for choice randomness; and a tendency parameter capturing a potential tendency to favour one shape over the other. Since the current study aims to replicate our previous findings, we will use the same model. The key hypothesis-driven variable of interest for analysis is the win learning rate.

    Measure derived from task performance (40mins)

  • Change in proportion of win-driven choices

    In addition to the computational model, we will also use a non-computational measure, the percentage of "win-driven choices". This is calculated from trials in which the win and loss are both associated with the same shape ("neutral" trials). What shape the participant chooses on the next trial will depend on whether s/he is more influenced by the current win or loss outcome. If the win outcome has a greater influence, the participant will choose the same shape again on the next trial. If the loss is more influential, the participant will avoid the current shape and instead choose the other shape. The proportion of "win-driven choices" is the proportion of trials in which participants choose the same shape on trial n+1 that was associated with both a win and a loss outcome on trial n. The key prediction is that this will be increased by online tDCS.

    Measure derived from task performance (40mins)

Secondary Outcomes (1)

  • Change in ability to adjust learning rate to volatility

    Measure derived from task performance (40mins)

Study Arms (2)

Bifrontal tDCS

EXPERIMENTAL

20 minutes of 2 mA transcranial direct current stimulation (tDCS), with the anode placed over the left dorsolateral prefrontal cortex and the cathode placed over the right dorsolateral prefrontal cortex (F3 and F4 according to the 10/20 international EEG system, respectively). The stimulation will be applied before or during task performance, depending on the condition assignment.

Device: Transcranial direct current stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Participants receive 20 minutes of sham tDCS, with the anode placed over the left dorsolateral prefrontal cortex and the cathode placed over the right dorsolateral prefrontal cortex (F3 and F4 according to the 10/20 international EEG system, respectively). In sham tDCS, stimulation starts with 8s fade in followed by 30s direct current followed by 5s fade out followed by 870s without any stimulation. The stimulation will be applied before or during task performance, depending on the condition assignment.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Electric current

Bifrontal tDCSSham tDCS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Participant has a score of \>9 on Beck's Depression Inventory II (BDI-II)
  • Fluent English-speaking
  • Right-handed

You may not qualify if:

  • Currently taking psychoactive medications
  • Personal or family history of epileptic fits or seizures
  • Family history of extreme mood fluctuations or bipolar disorder
  • Currently pregnant or current likelihood of becoming pregnant
  • Significant suicidal ideation or depression requiring immediate clinical referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FMRIB Centre, John Radcliffe Hospital, University of Oxford

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (8)

  • Browning M, Behrens TE, Jocham G, O'Reilly JX, Bishop SJ. Anxious individuals have difficulty learning the causal statistics of aversive environments. Nat Neurosci. 2015 Apr;18(4):590-6. doi: 10.1038/nn.3961. Epub 2015 Mar 2.

    PMID: 25730669BACKGROUND
  • Fritsch B, Reis J, Martinowich K, Schambra HM, Ji Y, Cohen LG, Lu B. Direct current stimulation promotes BDNF-dependent synaptic plasticity: potential implications for motor learning. Neuron. 2010 Apr 29;66(2):198-204. doi: 10.1016/j.neuron.2010.03.035.

    PMID: 20434997BACKGROUND
  • Gagne C, Zika O, Dayan P, Bishop SJ. Impaired adaptation of learning to contingency volatility in internalizing psychopathology. Elife. 2020 Dec 22;9:e61387. doi: 10.7554/eLife.61387.

    PMID: 33350387BACKGROUND
  • Kube T, Schwarting R, Rozenkrantz L, Glombiewski JA, Rief W. Distorted Cognitive Processes in Major Depression: A Predictive Processing Perspective. Biol Psychiatry. 2020 Mar 1;87(5):388-398. doi: 10.1016/j.biopsych.2019.07.017. Epub 2019 Jul 29.

    PMID: 31515055BACKGROUND
  • O'Shea J, Revol P, Cousijn H, Near J, Petitet P, Jacquin-Courtois S, Johansen-Berg H, Rode G, Rossetti Y. Induced sensorimotor cortex plasticity remediates chronic treatment-resistant visual neglect. Elife. 2017 Sep 12;6:e26602. doi: 10.7554/eLife.26602.

    PMID: 28893377BACKGROUND
  • Pulcu E, Browning M. Affective bias as a rational response to the statistics of rewards and punishments. Elife. 2017 Oct 4;6:e27879. doi: 10.7554/eLife.27879.

    PMID: 28976304BACKGROUND
  • Razza LB, Palumbo P, Moffa AH, Carvalho AF, Solmi M, Loo CK, Brunoni AR. A systematic review and meta-analysis on the effects of transcranial direct current stimulation in depressive episodes. Depress Anxiety. 2020 Jul;37(7):594-608. doi: 10.1002/da.23004. Epub 2020 Feb 26.

    PMID: 32101631BACKGROUND
  • Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.

    PMID: 19164589BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jacinta O'Shea, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
A study mode on the tDCS device is used, which requires the researcher to enter a code determining whether active or sham stimulation is applied. The codes have been assigned to the participants in a randomised manner by a researcher not involved in the stimulation sessions or assessment of the outcomes. All participants receive active tDCS in one session and sham tDCS in the other session in a randomised order.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Repeated-measures double-blinded research study comparing the effects of bifrontal tDCS to sham tDCS. Participants will take part in two testing sessions and will receive real and sham tDCS in counter-balanced order. Stimulation time (before vs. during task performance) will be included as a between-subject factor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 8, 2018

Study Start

February 2, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations