Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to investigate the efficacy of theta burst stimulation in individuals with gambling disorder. The main goal is to compare the severity of gambling problems following 2 weeks of intervention between active group and sham group. Participants will be randomized into active and sham group. The severity of gambling problems are assessed by self-reported questionaires.
Gambling disorder, formerly known as pathological gambling, is a gambling behavior that causes significant function impairment in personal, social, occupational domains. Currently there is no pharmacological treatment for gambling disorder and it is urgent to develop innovative treatment modalities. Image studies have found a link between prefrontal circuit dysfunction and behavioral disinhibition, which supports the use of non-invasive brain stimulation as a potential treatment for gambling disorder. In this study, 75 patients with gambling disorder will be randomly assigned in a 2:1 ratio to the intervention group (50 patients) and the control group (25 patients) on double-blind basis. The study duration is 2 weeks, with 10 sessions of 20 minutes each. The intervention group will receive repetitive transcranial magnetic stimulation at the left dorsolateral prefrontal cortex and pre-supplementary motor area, while the control group will receive sham stimulation. The Chinese version of the Problem Gambling Severity Index (PGSI), the Gambling Symptom Assessment Scale (G-SAS), and the Visual Analogue Scale (VAS) for craving will be administered at week 0, 2, 4, 8, and the change in gambling severity between the two groups will be compared by repeated measures ANOVA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active arm | Experimental | The intervention group will receive repetitive transcranial magnetic stimulation at the left dorsolateral prefrontal cortex and pre-supplementary motor area |
|
| Sham arm | Sham Comparator | the control group will receive sham stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| theta burst stimulation | Device | Magstim Rapid 2 Plus stimulator (Magstim Co., Ltd., Whitland, United Kingdom) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in gambling craving | Measured by visual analog scale, from 0-10 | Before intervention (week 0) and after intervention (week 2, 4) |
| Change in gambling severity | Measured by Gambling Symptom Assessment Scale, from 0-48 | Before intervention (week 0) and after intervention (week 2, 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depression severity | Measured by Beck Depression Inventory, from 0-63 | Before intervention (week 0) and after intervention (week 2, 4) |
| Change in anxiety severity | Measured by Beck Anxiety Inventory, from 0-63 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu-Ming Chang | Contact | 0978052951 | DAU66@tpech.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hu-Ming Chang | Taipei City Psychiatric Center, Taipei City Hospital, Taipei, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei City Hospital | Recruiting | Taipei | Taipei CITY | 105 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005715 | Gambling |
| ID | Term |
|---|---|
| D012309 | Risk-Taking |
| D001519 | Behavior |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
theta burst stimulation
Not provided
Not provided
Not provided
| sham stimulation | Device | sham stimulation |
|
| Before intervention (week 0) and after intervention (week 2, 4) |