NCT03669315: TMS-GD

Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation

Recruiting now Phase 3 Last updated 13 September 2018

What this trial tests

Phase 3 trial testing Transcranial Magnetic stimulation in Gambling Disorder in 40 participants. Currently enrolling.

Timeline

20 May 2018

Primary endpoint
1 December 2019

1 December 2019

Quick facts

Lead sponsor	CNS Onlus
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	20 May 2018
Primary completion	1 December 2019
Estimated completion	1 December 2019
Sites	1 location across Italy

Drugs / interventions tested

• Transcranial Magnetic stimulation — full drug profile →

Conditions studied

• Gambling Disorder — all drugs for Gambling Disorder →

Sponsor

CNS Onlus — full company profile →

Who can join

Adults 18 to 65, any sex, with Gambling Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. How to manage obsessive-compulsive disorder (OCD) under COVID-19: A clinician's guide from the International College of Obsessive Compulsive Spectrum Disorders (ICOCS) and the Obsessive-Compulsive and Related Disorders Research Network (OCRN) of the European College of Neuropsych
   Fineberg NA, Van Ameringen M, Drummond L, Hollander E, et al · · 2020 · cited 108× · PMID 32388123 · DOI 10.1016/j.comppsych.2020.152174
2. Clinical advances in obsessive-compulsive disorder: a position statement by the International College of Obsessive-Compulsive Spectrum Disorders.
   Fineberg NA, Hollander E, Pallanti S, Walitza S, et al · · 2020 · cited 92× · PMID 32433254 · DOI 10.1097/yic.0000000000000314
3. Efficacy of Continuous Theta Burst Stimulation to the Pre-supplementary Motor Area in Gambling Disorder: a Randomized Double-Blind Controlled Trial.
   Pallanti S, Camprodon JA, Di Ponzio M, Makris N. · · 2025 · PMID 42004899 · DOI 10.1007/s11469-023-01120-z
4. Methodological challenges in outcomes research for early-trials for implementation of new therapies in neuropediatric rare diseases.
   Acosta MT, Zaragoza Domingo S, Arango C, Bishop KI, et al · · 2025 · PMID 41108007 · DOI 10.1186/s13023-025-03814-0