Gambling Disorder Clinical Trial
— TMS-GDOfficial title:
Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
Verified date | September 2018 |
Source | CNS Onlus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this project the investigators propose a randomized double-blind placebo-controlled design in which 40 patients with GD will receive active or sham cTBS to the pre-SMA for 2 weeks. The investigators will combine TMS, multimodal structural and functional MRI and behavioral measures in order to identify circuit-level mechanisms of action and therapeutic targets (connectivity changes that explain clinical improvement) and assess the efficacy of TMS in modulating inhibitory control and symptom severity in this population.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 1, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | CNSOnlus, Institute of Neuroscience | Florence |
Lead Sponsor | Collaborator |
---|---|
CNS Onlus |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cTBS effects on gambling symptoms change | cTBS effects on gabling symptoms severity assessed through the PG-Y-BOCS (Yale-Brown Obsessive-Compulsive Scale modified for Pathological Gambling). Range from: 0-40 (higher values=worse symptoms) | Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up | |
Primary | cTBS effects on gambling symptoms change | cTBS effects on gabling symptoms severity assessed through the GUQ (Gambling Urges Questionnaire). Range from: 0-60 (higher values=worse symptoms) | Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up | |
Secondary | Acute mechanism of action | Functional MRI assessment | Day 1 | |
Secondary | Chronic mechanism of action | Functional MRI assessment | Day 10 |
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