Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial

Summary

Background: Gambling disorder (GD), is a behavioral addiction based on keeping play despite medical, economic and social consequences. GD is characterized by progressive and persistent brain circuits alterations (reward, stress, memory, impulse control and cognitive functions), so a possible treatment could be based on neuromodulation of specific brain areas. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation, which provides magnetic stimuli on certain brain areas parts with short and long-term effects. rTMS has the FDA approval for some neurological (headache) and psychiatric (treatment-resistant depression, obsessive-compulsive disorder) disease. Nowadays several evidence in scientific literature lead to a promise use of rTMS also in addiction field with a possible indication also for GD.

Objectives: the main outcome is to assess symptoms related to GD (craving, play frequencies, money lost) before and after rTMS stimulation on left dorsolateral prefrontal cortex (DLPFC).

Eligibility: Healthy, right-handed adults ages 18-65 with a diagnosis of GD. Design: This is a randomized, sham-controlled study. The study includes two phases:1) a rTMS continued treatment phase and 2) a follow-up without rTMS stimulation (30 days).

In order to be enrolled, participants will be screened with:

* Questionnaires
* Medical history
* Physical exam
* f-MRI

After being enrolled, baseline behavioral and imaging data will be collected. In particular, participants will submit:

* Questionnaires
* Functional MRI
* Cognitive tasks

During the continued rTMS phase, participants with gambling disorder will be randomized to receive real or sham rTMS. RTMS will be delivered during 5 outpatient treatment days, (3 times/die). After the last stimulation and at the end of the 30-days of follow-up period, subjects will undergo the neurocognitive and psychometric evaluation.

Twenty randomized patients of whole enrolled group will undergo fMRI at baseline and at the end of arTMS treatment phase.

Treatment includes:

* rTMS: A weak electrical current passes through a coil placed on the head. During each stimulation day, participants will receive three rTMS sessions (13 min), with a 50 min of interval.
* fMRI: Participants lie on a table that slides into a cylinder that takes pictures of the brain. They respond to images while in the scanner.
* Repeat of screening tests and questionnaires

Conditions

• Gambling
• Gambling Disorder
• Gambling, Pathological
• Gambling Problem

Interventions

DEVICE

Accelerated repetitive Transcranial Magnetic Stimulation

arTMS is a non-invasive brain stimulation technique. It will be used a MagPro R30 with a Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).

Sponsors & Collaborators

• ITAB - Institute for Advanced Biomedical Technologies

  lead OTHER

Principal Investigators

• Massimo di Giannantonio, MD · ITAB - Institute for Advanced Biomedical

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-01

Primary Completion

2025-11-30

Completion

2026-02-28