Gambling DisorderNCT03733808
High Frequency rTMS Over l-DLPFC in Gambling Disorder
A study testing Repetitive Transcranial Magnetic Stimulation in people with Gambling Disorder, run by Fondazione Novella Fronda at 1 site in Italy.
Trial summary
Gambling disorder (GD), currently considered a behavioral addiction, show substantial similarities with substance use disorders (SUDs) in terms of neurobiology and symptomatology. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gambling Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 11 Dec 2018to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65;
- Current DSM-5 diagnosis of Gambling Disorder;
- Right-handed;
Who cannot join
- Current DSM-5 diagnosis of Schizophrenia Spectrum and other Psychotic Disorders;
- 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);
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- 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;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Casa di Cura Park Villa Napoleon
Preganziol, Treviso, 31022
Franco Garonna, MD, 0039 3358007663, franco.garonna@alice.it
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Treatment of Gambling Disorder: a Pilot Study
Gambling disorder (GD), currently considered a behavioral addiction, show substantial similarities with substance use disorders (SUDs) in terms of neurobiology and symptomatology. In particular, alterations in prefrontal control circuit may underlie vulnerability to gambling- and drug-related cues and diminished cognitive control over craving, and negative emotions. Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) could represent a novel approach to remodel these brain circuits.
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.
Read the detailed description
Gambling disorder (GD) is a progressive and recurrent maladaptive pattern of gambling behavior, leading to impaired functioning.
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
- Gambling Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Keywords
- rTMS
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Non-invasive brain stimulation technique
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS treatment | Active comparator | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham rTMS treatment | Sham comparator | 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. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
High frequency rTMS effects on changes of the gambling symptoms severity
The main outcome will be defined as the difference in the variation between baseline and after treatment day 30 of the severity of gambling symptoms assessed through the G-SAS (Gambling Symptom Assessment Scale). Range from: 0-48 (higher values=worse symptoms)
Measured: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
Secondary outcomes (4)
High frequency rTMS effects on prefrontal hemodynamics activity in response to cue reactivity tasks
Functional near-infrared spectroscopy (fNIRS) assessment during cue reactivity task
Measured: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on the propensity for future reinforcers to maintain current responding
This decision making process will be evaluated through delay discounting paradigm. Basing on subject's responses and using of a hyperbolic function an k index will be calculate, indicating the rate with which the subjective value declines: smaller values (close to 0) indicate a preference for postponed rewards, larger values (> 0.5) indicate a preference for immediate rewards.
Measured: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on changes in decision-making ability linked to emotional and activation self-regulation functions
This decision making process will be evaluated through Iowa Gambling Task. Two types of indices will be calculated that measure participants' a) tendency to choose advantageously (where the choice of decks is likely to yield smaller rewards for each card drawn, but minimizes larger losses, over time) and their b) tendency to select from decks that offer infrequent (though larger) loss.
Measured: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on resting functional connectivity
Functional MRI assessment
Measured: Baseline- Day 90 (after 32 rTMS sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start11 Dec 2018
- Primary completionAug 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized, sham-controlled with a 1:1 allocation into 2 parallel arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Novella Fronda
- Sponsor type
- University, hospital or other
- Collaborators
- Casa di Cura Park Villa Napoleon, University of Padova, Istituto Italiano di Tecnologia
- Responsible party
- Sponsor
- Investigators
- Franco Garonna, MD, Principal investigator, Casa di Cura Park Villa NapoleonStefano Cardullo, PhD, Study chair, Fondazione Novella Fronda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733808
- Sponsor's protocol ID
- rTM20NG4MBLDSD
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) of the Dorsolateral Prefrontal Cortex for the Treatment of Gambling Disorder: a Pilot Study
- ClinicalTrials.gov ID
- NCT03733808
- Acronym / sponsor ID
- rTM20NG4MBLDSD
- Conditions
- Gambling Disorder
- Keywords
- rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione Novella FrondaUniversity, hospital or other
- Collaborators
- Casa di Cura Park Villa Napoleon, University of Padova, Istituto Italiano di Tecnologia
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gambling disorder (GD), currently considered a behavioral addiction, show substantial similarities with substance use disorders (SUDs) in terms of neurobiology and symptomatology. In particular, alterations in prefrontal control circuit may underlie vulnerability to gambling- and drug-related cues and diminished cognitive control over craving, and negative emotions. Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) could represent a novel approach to remodel these brain circuits.
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.
Detailed description
Gambling disorder (GD) is a progressive and recurrent maladaptive pattern of gambling behavior, leading to impaired functioning.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized, sham-controlled with a 1:1 allocation into 2 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Active rTMS treatment | Active comparator | Device: Repetitive Transcranial Magnetic StimulationActive 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. |
| Sham rTMS treatment | Sham comparator | Device: Repetitive Transcranial Magnetic StimulationSham 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65;
- Current DSM-5 diagnosis of Gambling Disorder;
- Right-handed;
Key exclusion criteria (12 listed)
- Current DSM-5 diagnosis of Schizophrenia Spectrum and other Psychotic Disorders;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationNon-invasive brain stimulation technique | Device | Active rTMS treatment, Sham rTMS treatment |
Primary outcome
High frequency rTMS effects on changes of the gambling symptoms severity
Time frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
The main outcome will be defined as the difference in the variation between baseline and after treatment day 30 of the severity of gambling symptoms assessed through the G-SAS (Gambling Symptom Assessment Scale). Range from: 0-48 (higher values=worse symptoms)
4 secondary outcomes
High frequency rTMS effects on prefrontal hemodynamics activity in response to cue reactivity tasks
Time frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on the propensity for future reinforcers to maintain current responding
Time frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on changes in decision-making ability linked to emotional and activation self-regulation functions
Time frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up
High frequency rTMS effects on resting functional connectivity
Time frame: Baseline- Day 90 (after 32 rTMS sessions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Garonna, MD principal investigator
Casa di Cura Park Villa Napoleon
Stefano Cardullo, PhD study chair
Fondazione Novella Fronda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Gambling Disorder, run by Fondazione Novella Fronda at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Graziella Madeo, MD, PhD (0039 3920170804, graziemadeo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High frequency rTMS effects on changes of the gambling symptoms severity (time frame: Baseline- Day 30 (after 16 rTMS sessions)- Day 60 (after 24 rTMS sessions)- Day 90 (after 32 rTMS sessions)- after 1 month follow-up- after 2 months follow-up- after 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.