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Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation

ConditionGambling Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCNS Onlus

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

DSM-5 diagnosis of Gambling Disorder

Age between 18 and 65 years

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic stimulation

    Device

    Neuromodulation tool

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Active cTBS treatmentActive comparator 1 intervention
Group B: Sham cTBS treatmentSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up
2

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)

Time frame
Baseline - Day 10 (after 10 cTBS sessions) - after 1 month follow-up

Secondary outcomes

1

Acute mechanism of action

Functional MRI assessment

Time frame
Day 1
2

Chronic mechanism of action

Functional MRI assessment

Time frame
Day 10

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CNS Onlus

Lead sponsor

Source ClinicalTrials.gov
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