Clinical trial NCT03464838: Effects of Transcranial Direct Current Stimulation (tDCS) in Gambling Disorder
Official title: The Role of Neuromodulation for Cognitive Processing and Behavioural Inhibition in Gambling Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pathological Gambling
Lead sponsor: University of East London
Sponsor class: OTHER
Collaborators: name: GambleAware
name: National Problem Gambling Clinic
First posted: 2018-03-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigation of the effects of transcranial direct current stimulation (tDCS) in combination with cognitive behavioural therapy (CBT) against the effects of CBT alone.
Primary purpose: TREATMENT

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.

Detailed description: The investigators aim to have a total of 32 participants diagnosed with gambling disorder with the Problem Gambling Severity Index (PGSI). There will be 16 participants per group having two different groups (real stimulation and sham). Real stimulation involves the application of tDCS stimulation and sham condition is used as a control (similar to a placebo).

Participants will attend 8 weekly sessions where they receive tDCS stimulation for 20 minutes, while complete CANTAB cognitive tasks that measure cognitive processes such us control inhibition and risk-taking behaviour. Electroencephalography (EEG) activity will be measured before and after tDCS.

Participants will also complete cognitive questionnaires (Pathological Gambling adapted Yale-Brown Obsessive Compulsive Scale (PG-YBOCS), Gambling Symptom Assessment Scale (G-SAS) and Visual Analogue Scale (VAS) for gambling cravings.

Eligibility criteria: Inclusion Criteria:

* Male or females between 18-65 years old diagnosed with disordered gambling based on the Problem Gambling Severity Index (PGSI) who can speak and read English and don't have any of the exclusion criteria.

Exclusion Criteria:

1. History or evidence of chronic or residual neurological disease.
2. A pacemaker or deep brain stimulation.
3. 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).
4. Intracerebral ischemia/history of bleeding.
5. Prior evidence of epileptic seizures, history of epilepsy.
6. History of head injury with loss of consciousness.
7. Any serious medical conditions (disease of the internal organs).
8. Pregnancy or breast-feeding.
9. Negative prescreening from the clinic psychiatrist.

Primary outcomes:
measure: Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
timeFrame: Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8
measure: Change in scores on the Visual Analogue Scale (VAS)
timeFrame: Change from baseline VAS scores at week 2, 3, 4, 5, 6, 7 and 8
measure: Change in scores on the Gambling Symptom Assessment Scale (G-SAS)
timeFrame: Change from baseline G-SAS scores at week 8
measure: Change in scores on the Cambridge Gambling Task (CGT)
timeFrame: Change from baseline CGT scores at week 8
Secondary outcomes:
measure: Change in scores on the Information Sampling Task (IST)
timeFrame: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
measure: Change in scores on the Stop Signal Task (SST)
timeFrame: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
measure: Change in encephalography (EEG) activity
timeFrame: Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of East London
Study officials:
References: