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Clinical Trials in Italy / NCT03669315
Recruiting Phase 3

Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation

NCT03669315 · tracked via the Priya Life Science Italy tracker
Sponsor
CNS Onlus
Phase
Phase 3
Started
2018-05-20
Last updated
2018-09-13

Condition(s) studied

Gambling Disorder

Investigational drug(s) / intervention(s)

Transcranial Magnetic stimulation

Transcranial Magnetic stimulation: Neuromodulation tool

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • cTBS effects on gambling symptoms change — Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up
    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)
  • cTBS effects on gambling symptoms change — Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up
    cTBS effects on gabling symptoms severity assessed through the GUQ (Gambling Urges Questionnaire). Range from: 0-60 (higher values=worse symptoms)

Trial sites (1)

FacilityCityRegionStatus
CNSOnlus, Institute of Neuroscience Florence Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03669315 on ClinicalTrials.gov ↗ ← All trials in Italy