Gambling Disorder Clinical Trial
Official title:
Exploring the Potential of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Gambling Disorder (GD)
Background: An imbalance between prefrontal cortex (PFC) and the mesolimbic reward system has
been suggested to contribute to GD. GD patients showed increased functional connectivity
between regions of the PFC and mesolimbic reward system, as well as reduced connectivity in
the area of the PFC. The altered interaction between prefrontal structures and the mesolimbic
reward system in GD shares similarity with functional organization reported in Substances Use
Disorders (SUDs), suggesting a more general pathophysiology for addictive disorders
Objectives: To test if rTMS can reduce craving and playing in Gambling Disorder, and also
affect several mood, behavioral and cognitive alterations associated with prolonged Gambling
Disorder.
Eligibility: Healthy, right-handed adults ages 18-65 who do have Gambling Disorder.
Design: This is a non-randomized, open label study. The study includes three phases: 1) a
rTMS continued treatment phase; 2) a rTMS follow-up; and 3) a no rTMS follow-up.
Prior to participating, participants will be screened with:
- Questionnaires
- Cognitive tests
- Medical history
- Physical exam
After being enrolled, baseline behavioral and imaging data will be collected. In particular,
participants will undergo:
- Questionnaires
- Cognitive tests
During the continued rTMS phase, participants with Gambling Disorder will receive real rTMS.
Repetitive TMS will be delivered during 10 outpatient treatment days, over 2 weeks (5
days/week). Following this phase, subjects will have 12 follow-up visits (once/weekly),
during which they will receive rTMS, and behavioral assessments will be performed. At the end
of the rTMS follow up period, participants will further receive 3 follow up visits (once a
month), during which rTMS will not be performed, but behavioral data will be collected.
Treatment includes:
- rTMS: A coil is placed on the head. Brief electrical current passes through the coil. At
each visit, participants will receive two rTMS sessions, with a 1hr interval between
sessions. At the beginning of each rTMS session, they view gambling-related images for
few minutes.
- Repeat of screening tests and questionnaires
Gambling Disorder (GD) is a complex addictive disorder involving fronto-striatal connectivity
and prefrontal top-down control modulation of reward-related brain areas. Repetitive
transcranial magnetic stimulation (rTMS) seems to reduce cravings and improve cognitive
function in substance dependent individuals. Moreover, rTMS has been shown to modulate
dopaminergic and glutamatergic transmission, both involved in GD pathophysiology. However,
the efficacy of rTMS in treating GD has not been evaluated and also, we lack a full
characterization of rTMS effects on other important aspects, including effects on mood,
cognition and changes in brain function. The purpose of this study is to investigate the
effects of repetitive Transcranial Magnetic Stimulation (rTMS) at 15 Hz frequency on the left
dorsolateral prefrontal cortex in patients affected by GD and to examine possible changes in
mood, cognition, and brain activity and functional connectivity associated with this
intervention. For this purpose, the investigators will recruit GD patients. After screening
and informed consent, participants will undergo active rTMS for two consecutive weeks (twice
a day) during the continued treatment phase, and a maintenance intervention (twice a week for
3 months), during the rTMS follow-up phase. Following this phase, participants will be
followed for further 3 months, during which no rTMS will be delivered but clinical data will
be collected.
Procedure: The project consists of: Screening Visit (baseline), Phase 1 (continued treatment
phase), Phase 2 (3 months- rTMS follow-up), Phase 3 (3 months follow-up without rTMS). First,
there will be a screening visit, where a clinical interview will be conducted and
questionnaires and tests will be administered to identify study participants who meet the
inclusion and exclusion criteria. Baseline clinical and cognitive data will be acquired. In
Phase 1, participants will receive 2 sessions of rTMS (active), twice per day for 10
consecutive days, for a total of 20 rTMS sessions. Following this, the investigators will
evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood
and cognition. In Phase 2 of the study, all participants will continue the treatment arm with
rTMS (15Hz) for three months. Participants will receive 2 sessions of rTMS (active) once per
week; clinical and cognitive data will be acquired once per month. The investigators will
evaluate the acute effect of treatment on relapse rate, gambling severity and craving, mood
and cognition. In Phase 3 of the study, participants will not receive any rTMS session.
Clinical and cognitive data will be acquired once per month for three months. The
investigators will evaluate the long-term effect of treatment on relapse rate, gambling
severity and craving, mood and cognition.
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