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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04290533
Ethics application status
Date submitted
18/02/2020
Date registered
2/03/2020

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
Other
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Verveer I, Hill AT, Franken IHA, Yucel M, van Dong... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04290533