The Effect of Transcranial Direct Current Stimulation on Decision Making and Cognitive Flexibility in Gambling Disorder

NCT ID: NCT03477799

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-29
• Study Completion Date: 2017-11-20

Brief Summary

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

Conditions

Gambling Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active

anodal stimulation over the right dlPFC

Group Type: ACTIVE_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

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

Sham

sham stimulation over the right dlPFC

Group Type: PLACEBO_COMPARATOR

Transcranial direct current stimulation

Intervention Type: DEVICE

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

Interventions

Transcranial direct current stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Zihni Soyata

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmet Z Soyata

Role: PRINCIPAL_INVESTIGATOR

Resident

Locations

Ahmet Zihni Soyata

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Soyata AZ, Aksu S, Woods AJ, Iscen P, Sacar KT, Karamursel S. Effect of transcranial direct current stimulation on decision making and cognitive flexibility in gambling disorder. Eur Arch Psychiatry Clin Neurosci. 2019 Apr;269(3):275-284. doi: 10.1007/s00406-018-0948-5. Epub 2018 Oct 26.

Reference Type: DERIVED

PMID: 30367243 (View on PubMed)

Other Identifiers

71146310-511.06-E368557

Identifier Type: -

Identifier Source: org_study_id