RecruitingPhase 3NCT03669315

Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation


Sponsor

CNS Onlus

Enrollment

40 participants

Start Date

May 20, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • DSM-5 diagnosis of Gambling Disorder
  • Age between 18 and 65 years

Exclusion Criteria9

  • any additional current psychiatric comorbidity, except for nicotine addiction;
  • 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;
  • serious suicide risk;
  • illness duration less than two years;
  • hospitalization in the last 6 months;
  • the inability to receive TMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
  • any major medical disease;
  • pregnancy or nursing of an infant;
  • the inability or refusal to provide written informed consent.

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Interventions

DEVICETranscranial Magnetic stimulation

Neuromodulation tool


Locations(1)

CNSOnlus, Institute of Neuroscience

Florence, Italy

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NCT03669315


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