Using theta burst stimulation to treat gambling disorder

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

This study is testing if a new brain stimulation treatment can help people with gambling problems feel better over two weeks compared to those who receive a fake treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Taipei City Hospital (Government)
• Locations: 1 site (Taipei, Taipei CITY)
• Trial ID: NCT05872750 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of theta burst stimulation in treating individuals with gambling disorder. Participants will be randomly assigned to either an active treatment group receiving real stimulation or a control group receiving sham stimulation over a period of two weeks. The severity of gambling problems will be assessed using self-reported questionnaires at multiple time points. This innovative approach seeks to address the lack of pharmacological treatments available for gambling disorder by targeting brain circuits associated with behavioral control.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who meet the DSM-5 criteria for gambling disorder.

Not a fit: Patients with major psychiatric illnesses requiring chronic medication or those with substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a novel non-invasive option for individuals struggling with gambling disorder.

How similar studies have performed: While the use of theta burst stimulation is a relatively novel approach for gambling disorder, similar non-invasive brain stimulation techniques have shown promise in treating other psychiatric conditions.

Eligibility criteria

Inclusion Criteria:

1. age between 18 and 65 years;
2. fulfilling at least 4 of the Diagnostic and Statistical Manual version 5 (DSM-5) criteria of gambling disorder for at least 12-month assessed by the Structured Clinical Interview

Exclusion Criteria:

1. Inability to provide informed consent or comprehend the study procedure;
2. A major psychiatric illness that required chronic psychotropic medication or inpatient treatment, including schizophrenia spectrum disorder, bipolar spectrum disorder, and major depressive disorder with psychotic features.
3. A current DSM-5 diagnosis of substance use disorder except nicotine use disorder or the use of one to two low-potency benzodiazepine tablets for sleep impairment;
4. Have known preexisting noise-induced hearing loss, concurrent treatment with ototoxic medications, or with cochlear implants.
5. Unstable medical illness, including malignancy, uncontrolled diabetes mellitus, unstable cardiac disease or recent myocardial infarction, or cerebrovascular or cardiovascular risk factors that require intensive medical management
6. On medications known to lower seizure threshold (e.g., TCA, bupropion, clozapine)
7. Implants controlled by physiological signals, including pacemaker, implantable cardioverter defibrillator, cochlear implant.
8. Metallic objects in the head, including stenting, suture.
9. Elevated risk of seizure due to traumatic brain history, seizure history, and head trauma, intracranial lesion, and alcohol or benzodiazepines withdrawal syndrome, stimulant intoxication.

Where this trial is running

Taipei, Taipei CITY

• Taipei City Hospital — Taipei, Taipei CITY, Taiwan (Recruiting)

Study contacts

• Principal investigator: Hu-Ming Chang — Taipei City Psychiatric Center, Taipei City Hospital, Taipei, Taiwan
• Study coordinator: Hu-Ming Chang

Conditions Gambling Disorder; theta burst stimulation