- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04290533
HD-tDCS Over the dACC in High Trait Impulsivity
May 13, 2021 updated by: Rebecca Segrave, Monash University
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3800
- Monash University, BrainPark
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Right-handed
- Score > 46 on SUPPS-P
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active 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).
|
Sham Comparator: Sham 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in error related negativity (ERN) measured by electroencephalography (EEG) after active and sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure changes in electrophysiological measures of error processing after active vs. sham HD-tDCS
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Change in NoGo N2 measured by electroencephalography (EEG)
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure changes in electrophysiological measures of early inhibitory control processes after active vs. sham HD-tDCS
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Change in NoGo P3 measured by electroencephalography (EEG) after active and sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure changes in electrophysiological measures of motor inhibitory control processes after active vs. sham HD-tDCS
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in percentage of correct nogo trials on Go/NoGo task after active vs. sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure the effect of active vs. sham HD-tDCS on accuracy on trials for which responses have to be inhibited.
Represents a measure of change in inhibitory control.
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Change in reaction times on Go trials during Go/NoGo task after active vs. sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure changes in speed of motor responses during Go/NoGo task differences after active vs. sham HD-tDCS
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Change in reaction times post incorrect trials during Go/NoGo task after active vs. sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
To measure the effect of active vs. sham HD-tDCS on post-error slowing as behavioural measure of error processing.
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Change in interference effect on multisource interference task (MSIT) after active vs. sham HD-tDCS
Time Frame: Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
The interference effect is calculated by subtracting the mean reaction time for congruent trials from the mean reaction time for incongruent trials.
A larger interference effect reflects worse performance and is suggested to reflect decreased dACC activity.
|
Baseline, directly after (active vs. sham) HD-tDCS, and 30 min after (active vs. sham) HD-tDCS.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trait impulsivity as measured by the The Short Version of the Urgency, Premeditation, Perseverance, Sensation Seeking and Positive Urgency Impulsive behaviour scale (SUPPS-P)
Time Frame: Baseline
|
The SUPPS-P is a widely used robust validated 20-item scale that measures five dimensions of impulsive behavior: negative urgency, premeditation, perseverance, sensation seeking and positive urgency.
Participants are asked to indicate how strongly or disagree they agree scale (1 = agree strongly to 4 = disagree strongly) with statements that relate to impulsive tendencies, such as "When I feel bad, I will often do things I later regret in order to make myself feel better now" and "I tend to lose control when I am in a great mood".
Higher scores indicate more impulsiveness.
For the current study, we used a cut-off score of 47 for high trait impulsivity.
This score was determined following analysis of a large database (n = 485) of mental health questionnaires completed by a community sample as part of an ongoing Monash University BrainPark study.
|
Baseline
|
Obsessional Behaviour Questionnaire-44 (OBQ-44)
Time Frame: Baseline
|
The OBQ-44 is a validated 44-item questionnaire, that measures the degree of obsessional beliefs.
Participants are asked to indicate how strongly or disagree they agree scale (1 = disagree very much to 7 = agree very much) with statements about responsibility/threat estimation (e.g.
"harmful events will happen unless I am careful"), perfectionism/certainty (e.g.
"I must be certain of my decisions"), and importance/control of thoughts (e.g.
"having nasty thoughts means I am a terrible person").
A higher score means participants experience stronger obsessional beliefs.
|
Baseline
|
Intolerance of Uncertainty Scale (IUS-12)
Time Frame: Baseline
|
IUS-12 is a short version of the original 27-item Intolerance of Uncertainty Scale that measures responses to uncertainty, ambiguous situations, and the future.
The 12 items are rated on a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).
A higher score indicates more intolerance of uncertainty.
|
Baseline
|
Demographic information
Time Frame: Baseline
|
Age, Gender, years of education
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2019
Primary Completion (Actual)
December 15, 2019
Study Completion (Actual)
January 15, 2020
Study Registration Dates
First Submitted
February 18, 2020
First Submitted That Met QC Criteria
February 26, 2020
First Posted (Actual)
March 2, 2020
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17612
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Impulsive Behavior
-
Supernus Pharmaceuticals, Inc.CompletedImpulsive Aggression Comorbid With ADHDUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisRecruiting
-
University Hospital, ToulouseRecruiting
-
National Institute on Drug Abuse (NIDA)Recruiting
-
Karolinska InstitutetStockholm UniversitySuspended
-
NYU Langone HealthNational Institute on Drug Abuse (NIDA)CompletedAddictionUnited States
-
Mind Medicine, Inc.Completed
-
Johannes Gutenberg University MainzCompletedAddictionAustria, Germany
-
Yale UniversityCompleted
-
Monash UniversityCompleted
Clinical Trials on Active High Definition transcranial Direct Current Stimulation (HD-tDCS)
-
University of TehranRecruitingHealthy VolunteersIran, Islamic Republic of
-
University of New MexicoUniversity of Miami; The City College of New York; The Mind Research Network; New... and other collaboratorsCompletedMild Traumatic Brain InjuryUnited States
-
Anhui Medical UniversityRecruitingTranscranial Direct Current Stimulation | Non Suicidal Self InjuryChina
-
Hôpital le VinatierRecruiting
-
Hôpital le VinatierNot yet recruiting
-
Kessler FoundationRecruitingTraumatic Brain Injury | Upper Extremity DysfunctionUnited States
-
Universitair Ziekenhuis BrusselRecruitingAlcohol Use Disorder (AUD)Belgium
-
University of MichiganCompletedTemporomandibular Joint Disorders
-
Spaulding Rehabilitation HospitalCompletedChronic PainUnited States