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

NCT ID: NCT03464838

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-06

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Pathological Gambling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Investigation of the effects of transcranial direct current stimulation (tDCS) in combination with cognitive behavioural therapy (CBT) against the effects of CBT alone.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Real Stimulation tDCS with CBT

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).

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS)

Intervention Type 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.

Cognitive Behavioural Therapy (CBT)

Intervention Type 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.

Sham tDCS with CBT

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).

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type 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.

Cognitive Behavioural Therapy (CBT)

Intervention Type 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.

Interventions

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Transcranial direct current stimulation (tDCS)

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.

Intervention Type DEVICE

Cognitive Behavioural Therapy (CBT)

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Noninvasive brain stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GambleAware

UNKNOWN

Sponsor Role collaborator

National Problem Gambling Clinic

UNKNOWN

Sponsor Role collaborator

University of East London

OTHER

Sponsor Role lead

Responsible Party

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Elena Gomis Vicent

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of East London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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241677

Identifier Type: OTHER

Identifier Source: secondary_id

UREC 1718 23

Identifier Type: -

Identifier Source: org_study_id

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