Using brain stimulation to improve control in gambling disorder
Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
PHASE3 · CNS Onlus · NCT03669315
This study is testing whether a type of brain stimulation can help people with gambling disorder gain better control over their gambling behavior.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | CNS Onlus (other) |
| Locations | 1 site (Florence) |
| Trial ID | NCT03669315 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of theta burst stimulation on patients diagnosed with Gambling Disorder. In a randomized double-blind placebo-controlled design, 40 participants will receive either active or sham transcranial magnetic stimulation (TMS) to the pre-supplementary motor area (pre-SMA) over two weeks. The study aims to explore the neural mechanisms underlying gambling behavior by combining TMS with multimodal structural and functional MRI, as well as behavioral assessments. The goal is to identify changes in brain connectivity that correlate with clinical improvements in inhibitory control and symptom severity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a DSM-5 diagnosis of Gambling Disorder.
Not a fit: Patients with significant psychiatric comorbidities or a history of severe mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance inhibitory control and reduce gambling impulses in affected individuals.
How similar studies have performed: Previous studies using TMS for various psychiatric conditions have shown promising results, suggesting potential efficacy for this novel application in Gambling Disorder.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. DSM-5 diagnosis of Gambling Disorder 2. Age between 18 and 65 years Exclusion Criteria: 1. any additional current psychiatric comorbidity, except for nicotine addiction; 2. a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition; 3. serious suicide risk; 4. illness duration less than two years; 5. hospitalization in the last 6 months; 6. the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives); 7. any major medical disease; 8. pregnancy or nursing of an infant; 9. the inability or refusal to provide written informed consent.
Where this trial is running
Florence
- CNSOnlus, Institute of Neuroscience — Florence, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gambling Disorder, Transcranial Magnetic Stimulation