NCT05872750

Theta Burst Stimulation for Gambling Disorder

Rolling Deep With Gambling Disorder: From Building up of Scales, Biomarkers to Therapeutic Innovation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Taipei City Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gambling Disorder

Interventions

Type	Name	Description
DEVICE	theta burst stimulation	Magstim Rapid 2 Plus stimulator (Magstim Co., Ltd., Whitland, United Kingdom)
DEVICE	sham stimulation	sham stimulation

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-05-24
• Last updated: 2023-05-24

Locations

1 site across 1 country: Taiwan