Effects of Transcranial Direct Current Stimulation (tDCS) in Gambling Disorder

NCT03464838 | Unknown

• 2 other identifiers: UREC 1718 23241677
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Gambling disorder is associated to high impulsivity and excessive risk-taking behaviour. These behavioural characteristics related to addiction are linked to cognitive processes in specific brain areas located in the prefrontal cortex (PFC). With the aim of studying the role of PFC in gambling disorder, the investigators employ transcranial current direct stimulation (tDCS), a noninvasive brain stimulation technique that applies a very weak electrical current to the superficial areas of the brain. The clinical phase of the research consists on studying the effects of tDCS in combination with cognitive behavioural therapy (CBT) in patients that attend the United Kingdom (UK) National Problem Gambling Clinic. The main objective of the project is to investigate whether the combination of tDCS and CBT can help to decrease impulsivity and risk-taking behaviour and therefore improve the treatment for gambling disorder.

Conditions

Pathological Gambling

Outcome Measures

Primary Outcomes (4)

• Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)

  It is a 10-item questionnaire that measures the gambling severity. The scores range from 0 to 4 in each question and the total score ranges from 0 to 40. The questions 1 to 5 assess urges and thoughts associated with gambling disorder, and the rest assess the behavioral component of the disorder. The total score will be calculated as well as the separate scores. Gambling severity will be higher with higher PG-YBOCS scores.

  Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8

• Change in scores on the Visual Analogue Scale (VAS)

  It is a horizontal line which length is 100 mm where the left side corresponds to the lower scores and the right side to the highest scores (it ranges from 0 to 10). The participant will draw a line where the level best represents their gambling cravings at the current time. The score will be calculated by measuring this line (in millimetres). The gambling cravings will be higher with higher VAS scores.

  Change from baseline VAS scores at week 2, 3, 4, 5, 6, 7 and 8

• Change in scores on the Gambling Symptom Assessment Scale (G-SAS)

  It is a 12-item scale to measure gambling symptoms. Each of the 12 questions has a score ranging from 0 to 4 based on the last week. It is useful to measure changes during treatment. The total score ranges from 0 to 48. The symptoms severity will be higher with higher G-SAS scores.

  Change from baseline G-SAS scores at week 8

• Change in scores on the Cambridge Gambling Task (CGT)

  Measures of gambling behaviour.

  Change from baseline CGT scores at week 8

Secondary Outcomes (3)

• Change in scores on the Information Sampling Task (IST)

  Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8

• Change in scores on the Stop Signal Task (SST)

  Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8

• Change in encephalography (EEG) activity

  Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8

Study Arms (2)

Real Stimulation tDCS with CBT

EXPERIMENTAL

16 participants will attend to one weekly tDCS stimulation session with intensity 1.8 milliamps for 8 consecutive weeks. Following the tDCS session, participants will attend to a cognitive behavioural therapy (CBT) session. One tDCS + CBT session per week (Total: 8 sessions).

Device: Transcranial direct current stimulation (tDCS); Behavioral: Cognitive Behavioural Therapy (CBT)

Sham tDCS with CBT

SHAM COMPARATOR

16 participants will attend to one weekly Sham tDCS session with intensity 0 milliamps for 8 consecutive weeks. Following the Sham tDCS session, participants will attend to a CBT session. One Sham tDCS + CBT session per week (Total: 8 sessions).

Device: Transcranial direct current stimulation (tDCS); Behavioral: Cognitive Behavioural Therapy (CBT)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that applies a very low electrical current to the scalp. tDCS will be applied with intensity of 1.8 milliamps in real stimulation condition and 0 milliamps in sham condition, during 20 minutes, using a high density (HD) tDCS montage over the Prefrontal Cortex (PFC). Electroencephalography (EEG) resting state activity will be measured before and after tDCS.

Also known as: Noninvasive brain stimulation

Real Stimulation tDCS with CBT; Sham tDCS with CBT

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

Cognitive Behavioural Therapy (CBT) is the current treatment available for disordered gamblers at the UK National Problem Gambling Clinic. During the therapy sessions patients acquire learning strategies, cognitive and motivational elements, and develop personal skills to help them improve the understanding of their problems.

Real Stimulation tDCS with CBT; Sham tDCS with CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History or evidence of chronic or residual neurological disease.
• A pacemaker or deep brain stimulation.
• Metal implants in head or neck area (e.g. postoperative clips after intracerebral aneurysm; arterial aneurysm in the vascular system, implantation of an artificial hearing aid).
• Intracerebral ischemia/history of bleeding.
• Prior evidence of epileptic seizures, history of epilepsy.
• History of head injury with loss of consciousness.
• Any serious medical conditions (disease of the internal organs).
• Pregnancy or breast-feeding.
• Negative prescreening from the clinic psychiatrist.

Sponsors & Collaborators

• University of East London: lead
• GambleAware: collaborator
• National Problem Gambling Clinic: collaborator

Study Sites (1)

University of East London

London, E15 4LZ, United Kingdom

Location

MeSH Terms

Conditions

Gambling

Interventions

Transcranial Direct Current Stimulation; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be allocated either to a tDCS Stimulation condition or to a tDCS Sham condition. Neither the investigator nor the participant will know to which condition the participant has been allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Investigation of the effects of transcranial direct current stimulation (tDCS) in combination with cognitive behavioural therapy (CBT) against the effects of CBT alone.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 14, 2018
• Study Start: March 6, 2019
• Primary Completion: April 30, 2020
• Study Completion: September 1, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

GB (1)