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

Primary Purpose

Pathological Gambling

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Cognitive Behavioural Therapy (CBT)
Sponsored by
University of East London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of East London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Stimulation tDCS with CBT

Sham tDCS with CBT

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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 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 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 in scores on the Cambridge Gambling Task (CGT)
Measures of gambling behaviour.

Secondary Outcome Measures

Change in scores on the Information Sampling Task (IST)
Measures of impulsivity
Change in scores on the Stop Signal Task (SST)
Measures of control inhibition
Change in encephalography (EEG) activity
Measures of endogenous oscillatory neural activity

Full Information

First Posted
February 27, 2018
Last Updated
April 15, 2019
Sponsor
University of East London
Collaborators
GambleAware, National Problem Gambling Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03464838
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of East London
Collaborators
GambleAware, National Problem Gambling Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Stimulation tDCS with CBT
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham tDCS with CBT
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Other Intervention Name(s)
Noninvasive brain stimulation
Intervention Description
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
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
Description
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.
Time Frame
Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8
Title
Change in scores on the Visual Analogue Scale (VAS)
Description
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.
Time Frame
Change from baseline VAS scores at week 2, 3, 4, 5, 6, 7 and 8
Title
Change in scores on the Gambling Symptom Assessment Scale (G-SAS)
Description
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.
Time Frame
Change from baseline G-SAS scores at week 8
Title
Change in scores on the Cambridge Gambling Task (CGT)
Description
Measures of gambling behaviour.
Time Frame
Change from baseline CGT scores at week 8
Secondary Outcome Measure Information:
Title
Change in scores on the Information Sampling Task (IST)
Description
Measures of impulsivity
Time Frame
Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Title
Change in scores on the Stop Signal Task (SST)
Description
Measures of control inhibition
Time Frame
Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Title
Change in encephalography (EEG) activity
Description
Measures of endogenous oscillatory neural activity
Time Frame
Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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.
Facility Information:
Facility Name
University of East London
City
London
ZIP/Postal Code
E15 4LZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The participant's data are de-identified (i.e. direct and indirect identifiers have been removed and replaced by a code. The researcher is able to link the code to the original identifiers and isolate the participant to whom the data relates). The Data Protection Act (1998), is the primary legislation on data storage. It states that personal data can be kept for as long as it is needed in an anonymised state for the study, after which time it must be destroyed.

Learn more about this trial

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

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