Pathological GamblingNCT03464838
Effects of Transcranial Direct Current Stimulation (tDCS) in Gambling Disorder
A study testing Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy (CBT) in people with Pathological Gambling, run by University of East London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Any serious medical conditions (disease of the internal organs).
- Pregnancy or breast-feeding.
- Negative prescreening from the clinic psychiatrist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Neuromodulation for Cognitive Processing and Behavioural Inhibition in Gambling Disorder
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.
Read the 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.
- Conditions
- Pathological Gambling
- Being tested
- Transcranial direct current stimulation (tDCS), Cognitive Behavioural Therapy (CBT)
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Also called Noninvasive brain stimulation
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: Transcranial direct current stimulation (tDCS); Behavioral: Cognitive Behavioural Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline G-SAS scores at week 8
Change in scores on the Cambridge Gambling Task (CGT)
Measures of gambling behaviour.
Measured: Change from baseline CGT scores at week 8
Secondary outcomes (3)
Change in scores on the Information Sampling Task (IST)
Measures of impulsivity
Measured: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Change in scores on the Stop Signal Task (SST)
Measures of control inhibition
Measured: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Change in encephalography (EEG) activity
Measures of endogenous oscillatory neural activity
Measured: Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start6 Mar 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East London
- Sponsor type
- University, hospital or other
- Collaborators
- GambleAware, National Problem Gambling Clinic
- Responsible party
- Principal investigator, Elena Gomis Vicent, University of East London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464838
- Sponsor's protocol ID
- UREC 1718 23
- Other IDs
- 241677
- Status last verified
- Apr 2019
- First submitted
- 27 Feb 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuromodulation for Cognitive Processing and Behavioural Inhibition in Gambling Disorder
- ClinicalTrials.gov ID
- NCT03464838
- Acronym / sponsor ID
- UREC 1718 23
- Conditions
- Pathological Gambling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of East LondonUniversity, hospital or other
- Collaborators
- GambleAware, National Problem Gambling Clinic
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Real Stimulation tDCS with CBT | Experimental | Device: Transcranial direct current stimulation (tDCS), Behavioral: Cognitive Behavioural Therapy (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). |
| Sham tDCS with CBT | Sham comparator | Device: Transcranial direct current stimulation (tDCS), Behavioral: Cognitive Behavioural Therapy (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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Also: Noninvasive brain stimulationTranscranial 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. | Device | Real Stimulation tDCS with CBT, Sham tDCS with CBT |
| 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. | Behavioural | Real Stimulation tDCS with CBT, Sham tDCS with CBT |
Primary outcome
Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
Time frame: Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8
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)
Time frame: Change from baseline VAS scores at week 2, 3, 4, 5, 6, 7 and 8
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)
Time frame: Change from baseline G-SAS scores at week 8
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)
Time frame: Change from baseline CGT scores at week 8
Measures of gambling behaviour.
3 secondary outcomes
Change in scores on the Information Sampling Task (IST)
Time frame: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Change in scores on the Stop Signal Task (SST)
Time frame: Change from baseline IST scores at week 2, 3, 4, 5, 6, 7 and 8
Change in encephalography (EEG) activity
Time frame: Change from baseline EEG activity in weeks 1, 2, 3, 4, 5, 6, 7 and 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Pathological Gambling
Not yet recruiting
Low-Intensity Focused Ultrasound for Gambling Disorder
Gambling Disorder, Gambling Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy (CBT) in people with Pathological Gambling, run by University of East London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) (time frame: Change from baseline PG-YBOCS scores at week 2, 3, 4, 5, 6, 7 and 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.