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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04290533




Registration number
NCT04290533
Ethics application status
Date submitted
18/02/2020
Date registered
2/03/2020
Date last updated
17/05/2021

Titles & IDs
Public title
HD-tDCS Over the dACC in High Trait Impulsivity
Scientific title
HD-tDCS Over the dACC in High Trait Impulsivity
Secondary ID [1] 0 0
17612
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impulsive Behavior 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Active High Definition transcranial Direct Current Stimulation (HD-tDCS)
Treatment: Devices - Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)

Experimental: Active HD-tDCS -

Sham Comparator: Sham HD-tDCS -


Treatment: Devices: Active High Definition transcranial Direct Current Stimulation (HD-tDCS)
TDCS is a non-invasive neuromodulation technique that modulates membrane potentials by means of small electrical currents. Electrical currents induced by tDCS electrodes produce an electrical field that modulates the excitability of brain areas. In the present HD-tDCS montage, one anodal electrode and four return electrodes are applied. Hereby, the anodal electrode modulates the excitability of the targeted area, whereas the other 4 electrodes return electrical currents that flow away from that area. Direct currents will be transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2) with a current intensity of 1.5 mA. The HD-tDCS session will last for 20 minutes in total, with a 60 sec ramp at the beginning and end of the session. The electrodes will be filled with conductive gel and plugged into an EEG cap, with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system).

Treatment: Devices: Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)
For the sham-condition, the placement of the electrodes was identical to active HD-tDCS stimulation with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system). The direct current, also transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2), was increased in a ramp-like fashion over 60 seconds until it reached 1.5 mA. Directly after ramp-up, the current intensity was gradually switched off over 60 seconds, followed by 20 minutes without active stimulation. Sham procedures for tDCS mimic the transient skin sensation at the beginning of active HD-tDCS, without producing any conditioning effects on the brain. Consequently, participants are reliably blinded for sham tDCS.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in error related negativity (ERN) measured by electroencephalography (EEG) after active and sham HD-tDCS
Timepoint [1] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Primary outcome [2] 0 0
Change in NoGo N2 measured by electroencephalography (EEG)
Timepoint [2] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Primary outcome [3] 0 0
Change in NoGo P3 measured by electroencephalography (EEG) after active and sham HD-tDCS
Timepoint [3] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Secondary outcome [1] 0 0
Change in percentage of correct nogo trials on Go/NoGo task after active vs. sham HD-tDCS
Timepoint [1] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Secondary outcome [2] 0 0
Change in reaction times on Go trials during Go/NoGo task after active vs. sham HD-tDCS
Timepoint [2] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Secondary outcome [3] 0 0
Change in reaction times post incorrect trials during Go/NoGo task after active vs. sham HD-tDCS
Timepoint [3] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
Secondary outcome [4] 0 0
Change in interference effect on multisource interference task (MSIT) after active vs. sham HD-tDCS
Timepoint [4] 0 0
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.

Eligibility
Key inclusion criteria
- Right-handed

- Score > 46 on SUPPS-P
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Score low on trait impulsivity as determined by a score of < 47 on the SUPPS-P short
form

- History of DSM-5 defined neurological illness, mental illness or traumatic brain
injury,

- Currently taking any psychoactive medications,

- Have metal anywhere in the head, except the mouth. This includes metallic objects such
as screws, plates and clips from surgical procedures.

- Currently pregnant or lactating,

- Being left-handed

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2020
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University, BrainPark - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Erasmus University Rotterdam
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
ZonMw: The Netherlands Organisation for Health Research and Development
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Psychological disorders characterized by impulsivity often show alterations in dorsal
anterior cingulate cortex (dACC) activity. Recent research has therefore focused on
non-invasive neurostimulation therapies for the modulation of functional activity in the
dACC. To date there has only been one proof-of-concept study providing evidence for
modulating dACC activity with non-invasive electrical neurostimulation (e.g. transcranial
electrical stimulation). Since transcranial Direct Current Stimulation (tDCS) is relatively
safe, tolerable, and mobile as compared to other neurostimulation techniques, it is
worthwhile looking further into the effects of tDCS on functional dACC activity. The aim of
the present research is to explore whether HD-tDCS can induce changes in the dACC in
individuals with high trait impulsivity (N=20) in a double-blind cross-over study. Functional
changes in dACC activity will be measured by the error related negativity (ERN), which is an
event related potential generated by the dACC. The ERN is less pronounced in people that
score high on impulsivity. It is therefore expect enhanced ERN amplitudes after HD-tDCS over
the dACC. In addition, performance on the multisource interference task will be used as
measure of dACC activity. It is hypothesize that increased dACC activity will be related to
decreased impulsivity in high impulsive individuals as shown by improved inhibitory control
on the Go/NoGo task. The results of the study may have implications for patient populations
that are characterized by impulsivity.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04290533
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries