- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477799
The Effect of Transcranial Direct Current Stimulation on Decision Making and Cognitive Flexibility in Gambling Disorder
The investigators conducted a double-blind randomised sham-controlled study. Upon enrollment into the study, participants were randomly assigned to one of two conditions: (i) active group: anodal stimulation over the right dlPFC (n = 10) or (ii) sham stimulation group (n = 10). Participants and raters were blinded to the condition.
Subsequently, the participants were administered the IGT and the Wisconsin Card Sorting Test by a trained neuropsychologist in a quiet laboratory. A computerized version of standard IGT was used. The order of the tasks performed in a single session was randomised.
After the psychiatric and neurocognitive assessment, participants received three sessions of 20-minute active or sham anodal tDCS (once a day, every other day).
Wisconsin Card Sorting Test and a modified version of Iowa Gambling Test were readministered after the last application. The order of the tasks was randomized again. A brief questionnaire on study blinding was also administered. Safety was assessed through open-ended questions based on the tDCS adverse events questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey, 34093
- Ahmet Zihni Soyata
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Participants meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for gambling disorder
- Being right-handed
- Being 18-65 years old
- Being drug-free
Exclusion Criteria:
- Current DSM-5 diagnosis of major depressive disorder
- Current or previous DSM-5 diagnosis of alcohol and substance use disorders, schizophrenia, bipolar disorder, or other psychotic disorder
- Drug Use in the past 4 weeks of any medication with known pro-convulsant action or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers)
- Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes,
- The presence of mental retardation diagnosis (previously identified)
- Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures
- Illiteracy, deficient language or refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active
anodal stimulation over the right dlPFC
|
Transcranial direct current stimulation (tDCS) is a safe method for non-invasively modulating cortical excitability through the use of weak electrical currents (usually of 1-2 mA) circulating between two scalp electrodes (i.e., an anode and a cathode) placed over the target cortical regions.
The effects of tDCS on brain activity are polarity-dependent, such that anodal stimulation generally enhances cortical excitability by depolarizing cell membranes and increasing neuronal firing rates, while cathodal stimulation generally results in the opposite effect.
Because of its neural effects, tDCS has been increasingly used to gauge the functional relationship between cognitive/behavioural dimensions and putatively relevant neurocircuitry
|
PLACEBO_COMPARATOR: Sham
sham stimulation over the right dlPFC
|
Transcranial direct current stimulation (tDCS) is a safe method for non-invasively modulating cortical excitability through the use of weak electrical currents (usually of 1-2 mA) circulating between two scalp electrodes (i.e., an anode and a cathode) placed over the target cortical regions.
The effects of tDCS on brain activity are polarity-dependent, such that anodal stimulation generally enhances cortical excitability by depolarizing cell membranes and increasing neuronal firing rates, while cathodal stimulation generally results in the opposite effect.
Because of its neural effects, tDCS has been increasingly used to gauge the functional relationship between cognitive/behavioural dimensions and putatively relevant neurocircuitry
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Iowa Gambling Task net score
Time Frame: Baseline, after tDCS treatment
|
Iowa Gambling Task net score is the total score of the task (between -100 and 100) that generally assesses the decision making under ambiguity, but also assesses the decision making under risk at the later stages.
Higher scores in the task represents better decision making and healthy people generally have scores above 8-10 in the task.
|
Baseline, after tDCS treatment
|
Changes in the number of perseverative errors in Wisconsin Card Sorting Task
Time Frame: Baseline, after tDCS treatment
|
Wisconsin Card Sorting Task is the widely used task to assess frontal lobe functions such as cognitive flexibility, set shifting and abstraction abilities.
The participants were required to match response cards to 4 stimulus cards along 1 of 3 dimensions (colour, form or number) on the basis of verbal feedback (correct or incorrect).
The participants were not given any information about the dimensions.
After sorting a series of 10 cards in 1 category, participants were asked to sort the cards in a different category.
The number of perseverative errors in Wisconsin Card Sorting Task is the most robust variable of the task to assess cognitive flexibility.
Higher scores show an impairment of cognitive flexibility
|
Baseline, after tDCS treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Z Soyata, resident
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 71146310-511.06-E368557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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