GamblingarTMSinGDNCT05016479
Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial
A study testing Accelerated repetitive Transcranial Magnetic Stimulation in people with Gambling and Gambling Disorder, run by ITAB - Institute for Advanced Biomedical Technologies.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gambling, Gambling Disorder, Gambling, Pathological
- What is being tested?
- Accelerated repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 28 Feb 2026
- 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
- Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
Who cannot join
- Current or pre-existing DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action, including antipsychotic medications, tricyclic antidepressants, and antihistamines drugs;
- Medical history with significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions and 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 or family history (1st degree relatives) of seizures other than febrile childhood seizures;
- Any psychiatric, medical or social condition whether or not listed above, due to which, according to the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
- For female patients: Pregnancy/breastfeeding.
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read more
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
Read the detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) is a neurostimulation technique that consists in the application of magnetic pulses in order to modulate local brain activity, opened up the possibility of interacting with dysfunctional brain circuits, selectively targeting gambling-related cognitive dysfunction.
The main outcome of the present study is to evaluate, in a population of GD patients, the effects of accelerated rTMS (arTMS) applied on Left Dorsolateral Prefrontal Cortex (LDLPFC) in terms of variations in gambling-related symptoms.
In order to investigate the possible effects of arTMS on brain connectivity, a subsample of patients will undergo a functional neuroimaging study based on fMRI.
The study includes 3 psychiatric assessments with psychometric testing: V1 (enrollment), V2 (day 5), V3 (week 4, follow-up).
At Visit 1 (enrollment) the researcher will fully inform the patient about the study, obtaining the patient's informed consent to participate in the study, and will determine the patient's eligibility. Patients will also undergo a battery of cognitive tasks and psychometric evaluation. The same neurocognitive and psychiatric assessment will be repeated during Visit 2 (day 5) and Visit 3 (4 Weeks).
The analysis of the neuroimaging data will allow to evaluate the effect of the active arTMS on brain connectivity (reward system, attention and executive control networks) investigate the association between these evidence and clinical variables.
- Conditions
- Gambling, Gambling Disorder, Gambling, Pathological, Gambling Problem
- Being tested
- Accelerated repetitive Transcranial Magnetic Stimulation
- Keywords
- arTMS, Transcranial Magnetic Stimulation, TMS, Gambling Disorder
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated repetitive Transcranial Magnetic StimulationDevice
Also called arTMS
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).
| Study group | Role | What they receive |
|---|---|---|
| Active arTMS (15 Hz) | Experimental | The treatment involves 15 Repetitive Transcranial Magnetic Stimlation sessions (3/daily for 5 consecutive days, each session lasts 13 min with an interval of 50 min). Coil is placed on the left dorsolateral prefrontal cortex (LDLPFC).The stimulation has a frequency of 15 Hz and a intensity of 120% of the individual resting motor threshold. Receives: Device: Accelerated repetitive Transcranial Magnetic Stimulation |
| Sham arTMS | Sham comparator | Sham group receives the same Repetitive Transcranial Magnetic Stimlation sessions of active compactors. However the interventions in the place group are with a superficial stimulation of scalp muscles only, in order to induce a sensation close to the one experienced with the real rTMS stimulation. Receives: Device: Accelerated repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gambling behavior assessed by Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
To assess the severity of gambling-related symptoms: Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS), 10-item clinician-administered questionnaire that assess gambling symptoms over a recent time interval
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in gambling behavior assessed by Gambling Symptom Assessment Scale (G-SAS)
a self-rated 5-point Likert scale with total score ranges from 0 to 48
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in gambling behavior assessed by TimeLine Follow Back (TLFB) - Gambling Version
in a multidimension retrospective interview focused on the quantitative assessment of gambling behavior
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in gambling behavior assessed by Visual Analogue Scale
an instrument applied to assess continuum variables, using a horizontal line on which the patient shell point his current state from left vertex (no gambling craving) to right vertex (maximum gambling craving).
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Secondary outcomes (21)
Change in attention / hyperactivity symptoms assessed by Adult ADHD Self-Report Scale (ASRS)
5-Likert questionnaire to assess the presence of disturbing symptoms attention / hyperactivity
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in emotional awareness assessed by Toronto Alexithymia Scale (TAS-20)
a self-report 5 point Likert scale with 20 items to assess emotional awareness. The total score goes from 20 to 100: non-alexithymia when the score is less than 51, borderline from 51 to 60 and alexithymia if the score is over 60
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in mood state assessed by Profile of Mood States (POMS)
a self-report, 5-point Likert scale to measure the current mood state through six dimensions of affect, including tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in search for sensations assessed by Sensation Seeking Scale V (SSS-V)
a scale created with the purpose of understanding traits as neuroticism, antisocial behavior and psychopathy. There are four different subscales: Thrill and Adventure Seeking, Disinhibition,Experience Seeking, Boredom Susceptibility. Each subscale contains 10 items, making a total of 40 items
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in hedonic tone assessed by Snaith-Hamilton Pleasure Scale (SHAPS)
a 14-item 4-point scale with a total score from 0 to 42
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in hedonic tone assessed by Temporal Experience of Pleasure Scale (TEPS)
a 18-item 6-point scale with a range from 20 to 108
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
to measure the social bonds of the subject with family members, friends, etc; this questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. There are 8 subscales : Phisical health, feelings, work, household duties, school/cpurse work, leisure time activities, social relations, general activities.
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in suicidal behaviours assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The scale identifies specific behaviors which may be indicative of an individual's intent to complete suicide. An individual exhibiting even a single behavior identified by the scale was 8 to 10 times more likely to complete suicide
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in psychopathological symptoms assessed by SCL-90
measuring both internalizing symptoms (depression, somatization, anxiety) and externalizing ones (aggression, hostility, impulsiveness) of psychiatric patients, general medicine and non-clinical subjects
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in food craving assessed by Food craving questionnaire (FCI)
a self-report 5-point Likert scale assess to evaluate food craving. The questionnaire consists of 28 items collected in 4 subscale: "high fat foods", "sweets", "carbohydrates", "fast foods"
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in sleep quality assessed by Insomnia severity index (ISI)
a self-report 5-point Likert questionnaire to estimate sleep quality in the last month. The total score range is from 0 to 28, in particular: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28)
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in nicotine craving assessed by Short Tobacco Craving Questionnaire (sTCQ)
a Likert based scale (1-7 score) to evaluate nicotine craving. The questionnaire consisted in 4 domines (emotionally, expectancy, compulsivity, purposufullness), each with 3 items
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in anxiety level assessed by Hamilton Anxiety Scale (HAM-A)
a 14-item 5-point scale with a total range score from 0 (min ) to 56 (max), that assesses anxiety symptoms exploring different domains "anxious mood", "tension" or "fears"
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in depressive symptoms assessed by Hamilton Depression Scale (HAM-D)
a interview with 20 items and total score is considered normal with range 0-7
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in manic symptoms assessed by Young Mania Rating Scale (YMRS)
a 11-item interview with total range score form 0 to 60
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in positive and negative symptoms assessed by Positive Affect and Negative Affect Scales (PANAS)
to measure any possible Collateral effect. PANAS is a 20-items 5-poin Likert questionnaire consisted in 2 subscale: Positive Affect Score and Negative Affect Score, with total range from 10 to 50 for each domains
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in impulsivness assessed by Barratt Impulsiveness Scale (BIS-11)
a 11-items self-report questionnaire to evaluate temperamental impulsive traits. BIS-11 consists in 3 subscale: "Attentional Impulsivity", "Motor Impulsivity" and "Nonplanning Impulsivity"
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Iowa gambling task (IGT)
a psychological task thought to simulate real-life decision making. Participants are presented with four virtual decks of cards on a computer screen. They are told that each deck holds cards that will either reward or penalize them, using game money. The goal of the game is to win as much money as possible. The decks differ from each other in the balance of reward versus penalty cards
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Go / No-Go Task
used to measure a participants capacity for sustained attention and response control. For example, a go/no-go test that requires a participant to perform an action given certain stimuli (e.g., press a button - Go) and inhibit that action under a different set of stimuli (e.g., not press that same button - No-Go).
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Stroop color-word task
a neuropsychological test extensively used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Wisconsin card-sorting task
a neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement. A number of stimulus cards are presented to the participant. The original WCST used paper cards and was carried out with the experimenter on one side of the desk facing the participant on the other
Measured: Baseline, after rTMS treatment (5 day), 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamblingStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITAB - Institute for Advanced Biomedical Technologies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pettorruso, ITAB - Institute for Advanced Biomedical Technologies
- Investigators
- Massimo di Giannantonio, MD, Principal investigator, ITAB - Institute for Advanced Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016479
- Sponsor's protocol ID
- richt1ie1
- Acronym
- arTMSinGD
- Status last verified
- Oct 2021
- First submitted
- 17 Aug 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05016479
- Acronym / sponsor ID
- arTMSinGD / richt1ie1
- Conditions
- Gambling, Gambling Disorder, Gambling, Pathological, Gambling Problem
- Keywords
- arTMS, Transcranial Magnetic Stimulation, TMS, Gambling Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ITAB - Institute for Advanced Biomedical TechnologiesUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 23 Aug 2021 (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.
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
Detailed description
Repetitive Transcranial Magnetic Stimulation (rTMS) is a neurostimulation technique that consists in the application of magnetic pulses in order to modulate local brain activity, opened up the possibility of interacting with dysfunctional brain circuits, selectively targeting gambling-related cognitive dysfunction.
The main outcome of the present study is to evaluate, in a population of GD patients, the effects of accelerated rTMS (arTMS) applied on Left Dorsolateral Prefrontal Cortex (LDLPFC) in terms of variations in gambling-related symptoms.
In order to investigate the possible effects of arTMS on brain connectivity, a subsample of patients will undergo a functional neuroimaging study based on fMRI.
The study includes 3 psychiatric assessments with psychometric testing: V1 (enrollment), V2 (day 5), V3 (week 4, follow-up).
At Visit 1 (enrollment) the researcher will fully inform the patient about the study, obtaining the patient's informed consent to participate in the study, and will determine the patient's eligibility. Patients will also undergo a battery of cognitive tasks and psychometric evaluation. The same neurocognitive and psychiatric assessment will be repeated during Visit 2 (day 5) and Visit 3 (4 Weeks).
The analysis of the neuroimaging data will allow to evaluate the effect of the active arTMS on brain connectivity (reward system, attention and executive control networks) investigate the association between these evidence and clinical variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, 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 arTMS (15 Hz) | Experimental | Device: Accelerated repetitive Transcranial Magnetic StimulationThe treatment involves 15 Repetitive Transcranial Magnetic Stimlation sessions (3/daily for 5 consecutive days, each session lasts 13 min with an interval of 50 min). Coil is placed on the left dorsolateral prefrontal cortex (LDLPFC).The stimulation has a frequency of 15 Hz and a intensity of 120% of the individual resting motor threshold. |
| Sham arTMS | Sham comparator | Device: Accelerated repetitive Transcranial Magnetic StimulationSham group receives the same Repetitive Transcranial Magnetic Stimlation sessions of active compactors. However the interventions in the place group are with a superficial stimulation of scalp muscles only, in order to induce a sensation close to the one experienced with the real rTMS stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current diagnosis of Gambling Disorder, based on the Diagnostic and Statistical Manual of Mental Disorder - Fifth Edition (DSM-5);
Key exclusion criteria (6 listed)
- Current or pre-existing DSM-5 diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder;
- Use in the past 4 weeks of any medication with known pro-convulsant action, including antipsychotic medications, tricyclic antidepressants, and antihistamines drugs;
- Medical history with significant neurological disorder, including organic brain disease, epilepsy, stroke, brain lesions and 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 or family history (1st degree relatives) of seizures other than febrile childhood seizures;
- Any psychiatric, medical or social condition whether or not listed above, due to which, according to the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient;
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 |
|---|---|---|
| Accelerated repetitive Transcranial Magnetic StimulationAlso: arTMSarTMS 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). | Device | Active arTMS (15 Hz), Sham arTMS |
Primary outcome
Change in gambling behavior assessed by Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
To assess the severity of gambling-related symptoms: Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS), 10-item clinician-administered questionnaire that assess gambling symptoms over a recent time interval
Change in gambling behavior assessed by Gambling Symptom Assessment Scale (G-SAS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
a self-rated 5-point Likert scale with total score ranges from 0 to 48
Change in gambling behavior assessed by TimeLine Follow Back (TLFB) - Gambling Version
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
in a multidimension retrospective interview focused on the quantitative assessment of gambling behavior
Change in gambling behavior assessed by Visual Analogue Scale
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
an instrument applied to assess continuum variables, using a horizontal line on which the patient shell point his current state from left vertex (no gambling craving) to right vertex (maximum gambling craving).
21 secondary outcomes
Change in attention / hyperactivity symptoms assessed by Adult ADHD Self-Report Scale (ASRS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in emotional awareness assessed by Toronto Alexithymia Scale (TAS-20)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in mood state assessed by Profile of Mood States (POMS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in search for sensations assessed by Sensation Seeking Scale V (SSS-V)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in hedonic tone assessed by Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in hedonic tone assessed by Temporal Experience of Pleasure Scale (TEPS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in suicidal behaviours assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in psychopathological symptoms assessed by SCL-90
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in food craving assessed by Food craving questionnaire (FCI)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in sleep quality assessed by Insomnia severity index (ISI)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in nicotine craving assessed by Short Tobacco Craving Questionnaire (sTCQ)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in anxiety level assessed by Hamilton Anxiety Scale (HAM-A)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in depressive symptoms assessed by Hamilton Depression Scale (HAM-D)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in manic symptoms assessed by Young Mania Rating Scale (YMRS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in positive and negative symptoms assessed by Positive Affect and Negative Affect Scales (PANAS)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in impulsivness assessed by Barratt Impulsiveness Scale (BIS-11)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Iowa gambling task (IGT)
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Go / No-Go Task
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Stroop color-word task
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Change in cognitive performance by Wisconsin card-sorting task
Time frame: Baseline, after rTMS treatment (5 day), 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Gambling
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Not yet recruiting
COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Gambling Disorder
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.
Massimo di Giannantonio, MD principal investigator
ITAB - Institute for Advanced Biomedical
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated repetitive Transcranial Magnetic Stimulation in people with Gambling and Gambling Disorder, run by ITAB - Institute for Advanced Biomedical Technologies.
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 1 inclusion and 6 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Mauro Pettorruso, MD, PhD (+39 0871 355 6901, mauro.pettorruso@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gambling behavior assessed by Yale Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS) (time frame: Baseline, after rTMS treatment (5 day), 4 weeks). The study lists 4 primary outcomes in all. 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 26 Oct 2021.