Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
36 participants
INTERVENTIONAL
2018-12-11
2022-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to evaluate High frequency (HF) rTMS over the left DLPFC as an efficacious treatment for reduction of gambling urges and behavior in a randomized double-blind placebo-controlled design in which 36 GD patients will receive active or sham rTMS for 12 weeks.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Repetitive Transcranial Magnetic Stimulation in Gambling Disorder
NCT03336879
Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial
NCT05016479
Repetitive Transcranial Magnetic Stimulation (rTMS) in The Treatment of Gambling Disorder in Indonesia
NCT06182137
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
NCT01560351
Modulating Inhibitory Control Networks in Gambling Disorder With Theta Burst Stimulation
NCT03669315
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
GD has been recategorized from an impulse control disorder to an addiction-related disorder in the fifth edition of Diagnostic and Statistical Manual of Mental (DSM-5) reflecting the growing evidence of the substantially overlapping between the neurobiology of GD and substance use disorders (SUDs). Both GD and SUDs are characterized by malfunction in reward, stress and cognitive-control circuits, which underlie manifestations such as compulsive gambling or compulsive drug consumption, craving, altered reward sensitivity, impaired self-control and decision-making processes. Particularly, similar alterations in cortico-limbic-striatal and prefrontal control circuits have been shown associated to the emergence of drug cravings and gambling urges. Hence, craving might be seen as a core component across addictions. Indeed, identifying and targeting the neurocircuit alterations underlying craving, may allow to treat this feature across different addictions with similar strategies.
In this regard, High frequency (HF) repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (l-DLPFC), is a promising approach for modulating brain circuits underlying cue-induced craving. Since alterations in these circuits have been shown to underlie the emergence of gambling urges, HF rTMS may represent a potential treatment also for GD patients.
Thus, the main goals of this clinical trial are to 1) assess whether HF rTMS over l-DLPFC reduces urges to gamble and problem behaviors gambling related; 2) investigate whether rTMS induces hemodynamics changes in DLPFC activity in response to specific tasks that elicit such areas as visual stimuli associated with gambling; 3) assess whether rTMS induces improvements in decision making processes of GD patients; and 4) evaluate the effects of HF rTMS over l-DLPFC on resting functional connectivity, focusing mainly in connectivity changes of cortical and subcortical regions involved in this disorder.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active rTMS treatment
Active High frequency rTMS will be administered with a Magventure MagPro Stimulator R30 using a butterfly coil. The stimulation protocol parameters will be set as follow: frequency of 15 Hz, of 100% of resting motor threshold (rMT), 40 trains, 60 pulses per train, 15 s intertrain-interval, 2400 pulses per session.
Repetitive Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique
Sham rTMS treatment
Sham rTMS will be administered with a Magventure MagPro Stimulator R30 using a butterfly sham coil. The same procedures of active High frequency rTMS will be used.
Repetitive Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Repetitive Transcranial Magnetic Stimulation
Non-invasive brain stimulation technique
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Current DSM-5 diagnosis of Gambling Disorder;
* Right-handed;
Exclusion Criteria
* Current DSM-5 diagnosis of Bipolar and related Disorders;
* Use in the past 4 weeks of any medication with known pro-convulsant action; or current regular use of any psychotropic medications (benzodiazepines, antipsychotic medications, tricyclic antidepressants, anti-epileptics, mood stabilizers);
* Any history of any clinically significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery, or personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes;
* Any personal history of seizures other than febrile childhood seizures;
* Presence of iron magnetic objects in the body contraindicated for treatments with rTMS and for participation in MRI sessions (pacemakers or other electrical devices implants, brain stimulators, some types of dental implants, aneurysm clips, metal implants, permanent eyeliner, fragments of projectile);
* Inability to remain lying on the back for up to 2 hours in the MRI plant;
* Current DSM-5 diagnosis of any Substance Use disorder with the exception of Tobacco Use Disorder and Mild Alcohol Use Disorder;
* Positive drug urine test to one or more classes of substances of abuse;
* For female subjects: pregnancy or breastfeeding in progress;
* Judicial provision that includes a cure in progress or if the subject is already engaged in a cure for gambling disorder;
* Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Casa di Cura Park Villa Napoleon
UNKNOWN
University of Padova
OTHER
Istituto Italiano di Tecnologia
OTHER
Fondazione Novella Fronda
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Franco Garonna, MD
Role: PRINCIPAL_INVESTIGATOR
Casa di Cura Park Villa Napoleon
Stefano Cardullo, PhD
Role: STUDY_CHAIR
Fondazione Novella Fronda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Casa di Cura Park Villa Napoleon
Preganziol, Treviso, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rTM20NG4MBLDSD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.