Effects of Transcranial Direct Current Stimulation (tDCS) in Gambling Disorder
NCT ID: NCT03464838
Last Updated: 2019-04-16
Study Results
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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UNKNOWN
NA
32 participants
INTERVENTIONAL
2019-03-06
2020-09-01
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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).
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.
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.
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).
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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GambleAware
UNKNOWN
National Problem Gambling Clinic
UNKNOWN
University of East London
OTHER
Responsible Party
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Elena Gomis Vicent
Principal Investigator
Locations
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University of East London
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
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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